Pregnancy
Conditions
Keywords
DHA, childhood development
Brief summary
This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
Detailed description
Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
Interventions
600 mg DHA capsule
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
Sponsors
Study design
Eligibility
Inclusion criteria
* Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound) * Agree to consume study capsules from enrollment until delivery * Agree to return to the study center for delivery * BMI \< 40 * No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive) * Available by telephone
Exclusion criteria
* Less than 16 or greater than 35 years of age * BMI \< 40 * Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive * Expecting multiple infants * Diabetes or gestational diabetes at baseline * Elevated blood pressure due to any cause * Not planning to return to the study center for delivery * Gestational age at baseline \< 8 weeks or \>20 weeks * Unable or unwilling to agree to consume capsules until delivery * Unable to provide informed consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 36 Months | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. |
| Cognitive Function Score - Peabody Picture Vocabulary Test | 60 Months | The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15. |
| Cognitive Function Score - Test of Preschool Early Literacy | 42 Months | The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15. |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 36 Months | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adaptive Regulation Assessment | 36 Months | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 4 years | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. |
| Anthropometrics: Weight-for-age | 2 years | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). |
| Heart Rate | 4 years | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. |
| Diastolic Blood Pressure | 4 years | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. |
| Anthropometrics: Height-for-Age | 2 years | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. |
| Anthropometrics: Body Mass Index-for-age | 2 years | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2. |
| Anthropometrics: Head Circumference-for-age | 2 years | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. |
| Dietary Intake | 2 years | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 7/17/2008 to 4/24/2012.
Pre-assignment details
Participants were required to have been enrolled in the parent trial.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Capsule Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA | 91 |
| DHA Capsule DHA: 600 mg DHA capsule | 99 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Moved out of area | 5 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo Capsule | DHA Capsule | Total |
|---|---|---|---|
| Age, Continuous | 2.01 years STANDARD_DEVIATION 0.03 | 2.01 years STANDARD_DEVIATION 0.03 | 2.01 years STANDARD_DEVIATION 0.03 |
| Race/Ethnicity, Customized Black | 33 Participants | 33 Participants | 66 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Not Black | 58 Participants | 66 Participants | 124 Participants |
| Race/Ethnicity, Customized Not Hispanic | 81 Participants | 90 Participants | 171 Participants |
| Region of Enrollment United States | 91 Participants | 99 Participants | 190 Participants |
| Sex: Female, Male Female | 40 Participants | 55 Participants | 95 Participants |
| Sex: Female, Male Male | 51 Participants | 44 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Cognitive Function Score - Peabody Picture Vocabulary Test
The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Time frame: 60 Months
Population: Missing data due to attrition, missed appointments, refusals, or questionable test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Cognitive Function Score - Peabody Picture Vocabulary Test | 101.07 units on a scale | Standard Deviation 14.92 |
| DHA Capsule | Cognitive Function Score - Peabody Picture Vocabulary Test | 102.35 units on a scale | Standard Deviation 15.33 |
Cognitive Function Score - Test of Preschool Early Literacy
The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Time frame: 42 Months
Population: Missing data due to attrition, missed appointments, refusals, or questionable test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Cognitive Function Score - Test of Preschool Early Literacy | 92.99 units on a scale | Standard Deviation 18.76 |
| DHA Capsule | Cognitive Function Score - Test of Preschool Early Literacy | 95.08 units on a scale | Standard Deviation 18.8 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 36 Months
Population: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 98.78 units on a scale | Standard Deviation 15.43 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 98.75 units on a scale | Standard Deviation 15.75 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 48 Months
Population: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 97.52 units on a scale | Standard Deviation 15.32 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 99.72 units on a scale | Standard Deviation 16.1 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 72 Months
Population: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 100.67 units on a scale | Standard Deviation 14.7 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | 102.21 units on a scale | Standard Deviation 14.02 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 48 Months
Population: Missing data due to attrition, missed appointments, refusals, or questionable test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 99.30 units on a scale | Standard Deviation 15.31 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 100.13 units on a scale | Standard Deviation 16.13 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 36 Months
Population: Missing data due to attrition, missed appointments, refusals, or questionable test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 100.98 units on a scale | Standard Deviation 14.22 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 101.10 units on a scale | Standard Deviation 16.51 |
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Time frame: 72 Months
Population: Missing data due to attrition, missed appointments, refusals, or questionable test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 101.53 units on a scale | Standard Deviation 14.2 |
| DHA Capsule | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | 102.44 units on a scale | Standard Deviation 14.88 |
Adaptive Regulation Assessment
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Time frame: 72 Months
Population: Missing data due to attrition, missed appointments, refusals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Capsule | Adaptive Regulation Assessment | Externalizing Problems | 50.10 T-scores | Standard Deviation 9.68 |
| Placebo Capsule | Adaptive Regulation Assessment | Internalizing Problems | 46.80 T-scores | Standard Deviation 7.8 |
| Placebo Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 48.99 T-scores | Standard Deviation 8.09 |
| Placebo Capsule | Adaptive Regulation Assessment | Adaptive Skills | 51.80 T-scores | Standard Deviation 8.09 |
| DHA Capsule | Adaptive Regulation Assessment | Adaptive Skills | 49.73 T-scores | Standard Deviation 9.77 |
| DHA Capsule | Adaptive Regulation Assessment | Externalizing Problems | 49.37 T-scores | Standard Deviation 6.76 |
| DHA Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 49.17 T-scores | Standard Deviation 6.72 |
| DHA Capsule | Adaptive Regulation Assessment | Internalizing Problems | 45.96 T-scores | Standard Deviation 8.35 |
Adaptive Regulation Assessment
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Time frame: 36 Months
Population: Missing data due to attrition, missed appointments, refusals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Capsule | Adaptive Regulation Assessment | Externalizing Problems | 48.17 T-scores | Standard Deviation 6.86 |
| Placebo Capsule | Adaptive Regulation Assessment | Internalizing Problems | 49.31 T-scores | Standard Deviation 9.67 |
| Placebo Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 47.99 T-scores | Standard Deviation 7.13 |
| Placebo Capsule | Adaptive Regulation Assessment | Adaptive Skills | 54.00 T-scores | Standard Deviation 7.49 |
| DHA Capsule | Adaptive Regulation Assessment | Adaptive Skills | 52.56 T-scores | Standard Deviation 7.23 |
| DHA Capsule | Adaptive Regulation Assessment | Externalizing Problems | 49.11 T-scores | Standard Deviation 7.85 |
| DHA Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 49.46 T-scores | Standard Deviation 6.85 |
| DHA Capsule | Adaptive Regulation Assessment | Internalizing Problems | 49.10 T-scores | Standard Deviation 8.05 |
Adaptive Regulation Assessment
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Time frame: 48 Months
Population: Missing data due to attrition, missed appointments, refusals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Capsule | Adaptive Regulation Assessment | Externalizing Problems | 48.87 T-scores | Standard Deviation 8.22 |
| Placebo Capsule | Adaptive Regulation Assessment | Internalizing Problems | 47.30 T-scores | Standard Deviation 8.65 |
| Placebo Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 49.42 T-scores | Standard Deviation 8.62 |
| Placebo Capsule | Adaptive Regulation Assessment | Adaptive Skills | 50.15 T-scores | Standard Deviation 8.76 |
| DHA Capsule | Adaptive Regulation Assessment | Adaptive Skills | 47.72 T-scores | Standard Deviation 8.4 |
| DHA Capsule | Adaptive Regulation Assessment | Externalizing Problems | 50.08 T-scores | Standard Deviation 8.22 |
| DHA Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 50.59 T-scores | Standard Deviation 7.2 |
| DHA Capsule | Adaptive Regulation Assessment | Internalizing Problems | 47.46 T-scores | Standard Deviation 8.73 |
Adaptive Regulation Assessment
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Time frame: 60 Months
Population: Missing data due to attrition, missed appointments, refusals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Capsule | Adaptive Regulation Assessment | Externalizing Problems | 48.94 T-scores | Standard Deviation 8.71 |
| Placebo Capsule | Adaptive Regulation Assessment | Internalizing Problems | 49.99 T-scores | Standard Deviation 7.96 |
| Placebo Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 50.17 T-scores | Standard Deviation 7.66 |
| Placebo Capsule | Adaptive Regulation Assessment | Adaptive Skills | 52.09 T-scores | Standard Deviation 8.18 |
| DHA Capsule | Adaptive Regulation Assessment | Adaptive Skills | 50.96 T-scores | Standard Deviation 8.13 |
| DHA Capsule | Adaptive Regulation Assessment | Externalizing Problems | 50.43 T-scores | Standard Deviation 9.22 |
| DHA Capsule | Adaptive Regulation Assessment | Behavioral Symptoms | 50.78 T-scores | Standard Deviation 8.19 |
| DHA Capsule | Adaptive Regulation Assessment | Internalizing Problems | 49.21 T-scores | Standard Deviation 8.75 |
Anthropometrics: Body Composition
Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population.
Time frame: 5 to 5.5 years old
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Composition | Fat Mass | 4.89 Kilogram (kg) | Standard Deviation 1.59 |
| Placebo Capsule | Anthropometrics: Body Composition | Fat Free Mass | 14.60 Kilogram (kg) | Standard Deviation 2.31 |
| DHA Capsule | Anthropometrics: Body Composition | Fat Mass | 5.17 Kilogram (kg) | Standard Deviation 1.66 |
| DHA Capsule | Anthropometrics: Body Composition | Fat Free Mass | 15.18 Kilogram (kg) | Standard Deviation 2.1 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 2.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.65 Body mass index (kg/m2) | Standard Deviation 1.37 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.92 Body mass index (kg/m2) | Standard Deviation 1.27 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.27 Body mass index (kg/m2) | Standard Deviation 1.83 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.58 Body mass index (kg/m2) | Standard Deviation 1.97 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.57 Body mass index (kg/m2) | Standard Deviation 2.51 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.81 Body mass index (kg/m2) | Standard Deviation 2.27 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.46 Body mass index (kg/m2) | Standard Deviation 2.22 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.68 Body mass index (kg/m2) | Standard Deviation 1.95 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.12 Body mass index (kg/m2) | Standard Deviation 1.51 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.49 Body mass index (kg/m2) | Standard Deviation 1.74 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.18 Body mass index (kg/m2) | Standard Deviation 1.38 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.56 Body mass index (kg/m2) | Standard Deviation 1.46 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 3.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.21 Body mass index (kg/m2) | Standard Deviation 1.36 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.57 Body mass index (kg/m2) | Standard Deviation 1.32 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 3 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 16.44 Body mass index (kg/m2) | Standard Deviation 1.33 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 16.67 Body mass index (kg/m2) | Standard Deviation 1.25 |
Anthropometrics: Body Mass Index-for-age
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Time frame: 2 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Body Mass Index-for-age | 17.13 Body mass index (kg/m^2) | Standard Deviation 1.53 |
| DHA Capsule | Anthropometrics: Body Mass Index-for-age | 17.31 Body mass index (kg/m^2) | Standard Deviation 1.28 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 51.04 Centimeters (cm) | Standard Deviation 1.48 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 51.37 Centimeters (cm) | Standard Deviation 1.48 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 2 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 48.40 Centimeters (cm) | Standard Deviation 1.29 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 48.50 Centimeters (cm) | Standard Deviation 1.38 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 2.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 49.18 Centimeters (cm) | Standard Deviation 1.36 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 49.21 Centimeters (cm) | Standard Deviation 1.37 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 3 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 49.64 Centimeters (cm) | Standard Deviation 1.34 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 49.75 Centimeters (cm) | Standard Deviation 1.34 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 3.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 50.05 Centimeters (cm) | Standard Deviation 1.35 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 50.15 Centimeters (cm) | Standard Deviation 1.28 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 50.47 Centimeters (cm) | Standard Deviation 1.37 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 50.62 Centimeters (cm) | Standard Deviation 1.33 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 50.78 Centimeters (cm) | Standard Deviation 1.36 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 50.95 Centimeters (cm) | Standard Deviation 1.42 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 51.48 Centimeters (cm) | Standard Deviation 1.42 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 51.58 Centimeters (cm) | Standard Deviation 1.42 |
Anthropometrics: Head Circumference-for-age
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Head Circumference-for-age | 51.77 Centimeters (cm) | Standard Deviation 1.51 |
| DHA Capsule | Anthropometrics: Head Circumference-for-age | 51.93 Centimeters (cm) | Standard Deviation 1.59 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 113.41 Centimeters (cm) | Standard Deviation 4.39 |
| DHA Capsule | Anthropometrics: Height-for-Age | 114.01 Centimeters (cm) | Standard Deviation 4.34 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 110.03 Centimeters (cm) | Standard Deviation 4.3 |
| DHA Capsule | Anthropometrics: Height-for-Age | 110.58 Centimeters (cm) | Standard Deviation 4.23 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 2 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 85.91 Centimeters (cm) | Standard Deviation 3.42 |
| DHA Capsule | Anthropometrics: Height-for-Age | 86.54 Centimeters (cm) | Standard Deviation 3.09 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 106.39 Centimeters (cm) | Standard Deviation 4.23 |
| DHA Capsule | Anthropometrics: Height-for-Age | 107.11 Centimeters (cm) | Standard Deviation 4.09 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 102.77 Centimeters (cm) | Standard Deviation 3.82 |
| DHA Capsule | Anthropometrics: Height-for-Age | 103.32 Centimeters (cm) | Standard Deviation 3.91 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 116.76 Centimeters (cm) | Standard Deviation 4.74 |
| DHA Capsule | Anthropometrics: Height-for-Age | 117.22 Centimeters (cm) | Standard Deviation 4.6 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 3.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 98.96 Centimeters (cm) | Standard Deviation 3.79 |
| DHA Capsule | Anthropometrics: Height-for-Age | 99.27 Centimeters (cm) | Standard Deviation 3.58 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 3 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 94.90 Centimeters (cm) | Standard Deviation 3.48 |
| DHA Capsule | Anthropometrics: Height-for-Age | 95.29 Centimeters (cm) | Standard Deviation 3.52 |
Anthropometrics: Height-for-Age
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Time frame: 2.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Height-for-Age | 90.66 Centimeters (cm) | Standard Deviation 3.1 |
| DHA Capsule | Anthropometrics: Height-for-Age | 91.17 Centimeters (cm) | Standard Deviation 3.69 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 22.68 Kilogram (kg) | Standard Deviation 4.16 |
| DHA Capsule | Anthropometrics: Weight-for-age | 23.14 Kilogram (kg) | Standard Deviation 3.66 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 21.23 Kilogram (kg) | Standard Deviation 3.5 |
| DHA Capsule | Anthropometrics: Weight-for-age | 21.73 Kilogram (kg) | Standard Deviation 3.18 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 19.75 Kilogram (kg) | Standard Deviation 2.85 |
| DHA Capsule | Anthropometrics: Weight-for-age | 20.33 Kilogram (kg) | Standard Deviation 3.05 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 4.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 18.29 Kilogram (kg) | Standard Deviation 2.38 |
| DHA Capsule | Anthropometrics: Weight-for-age | 18.96 Kilogram (kg) | Standard Deviation 2.55 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 17.13 Kilogram (kg) | Standard Deviation 2.11 |
| DHA Capsule | Anthropometrics: Weight-for-age | 17.71 Kilogram (kg) | Standard Deviation 2.1 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 3.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 15.90 Kilogram (kg) | Standard Deviation 1.91 |
| DHA Capsule | Anthropometrics: Weight-for-age | 16.36 Kilogram (kg) | Standard Deviation 1.85 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 3 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 14.83 Kilogram (kg) | Standard Deviation 1.76 |
| DHA Capsule | Anthropometrics: Weight-for-age | 15.16 Kilogram (kg) | Standard Deviation 1.6 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 2 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 12.66 Kilogram (kg) | Standard Deviation 1.51 |
| DHA Capsule | Anthropometrics: Weight-for-age | 12.99 Kilogram (kg) | Standard Deviation 1.44 |
Anthropometrics: Weight-for-age
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Time frame: 2.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Anthropometrics: Weight-for-age | 13.70 Kilogram (kg) | Standard Deviation 1.66 |
| DHA Capsule | Anthropometrics: Weight-for-age | 14.08 Kilogram (kg) | Standard Deviation 1.51 |
Diastolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Diastolic Blood Pressure | 62.5 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| DHA Capsule | Diastolic Blood Pressure | 61.5 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
Diastolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Diastolic Blood Pressure | 60.1 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| DHA Capsule | Diastolic Blood Pressure | 59.0 Millimeters of mercury (mmHg) | Standard Deviation 5.3 |
Diastolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Diastolic Blood Pressure | 58.9 Millimeters of mercury (mmHg) | Standard Deviation 5.9 |
| DHA Capsule | Diastolic Blood Pressure | 58.3 Millimeters of mercury (mmHg) | Standard Deviation 7.7 |
Diastolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Diastolic Blood Pressure | 63.3 Millimeters of mercury (mmHg) | Standard Deviation 9.5 |
| DHA Capsule | Diastolic Blood Pressure | 61.0 Millimeters of mercury (mmHg) | Standard Deviation 6.8 |
Diastolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Diastolic Blood Pressure | 62.1 Millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| DHA Capsule | Diastolic Blood Pressure | 58.8 Millimeters of mercury (mmHg) | Standard Deviation 7.7 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1412 kilocalorie | Standard Deviation 380 |
| DHA Capsule | Dietary Intake | 1466 kilocalorie | Standard Deviation 479 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1557 kilocalorie | Standard Deviation 436 |
| DHA Capsule | Dietary Intake | 1532 kilocalorie | Standard Deviation 458 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1655 kilocalorie | Standard Deviation 487 |
| DHA Capsule | Dietary Intake | 1495 kilocalorie | Standard Deviation 469 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 2.5 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1256 kilocalorie | Standard Deviation 413 |
| DHA Capsule | Dietary Intake | 1234 kilocalorie | Standard Deviation 396 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 3 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1364 kilocalorie | Standard Deviation 418 |
| DHA Capsule | Dietary Intake | 1285 kilocalorie | Standard Deviation 415 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 3.5 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1340 kilocalorie | Standard Deviation 361 |
| DHA Capsule | Dietary Intake | 1275 kilocalorie | Standard Deviation 407 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1468 kilocalorie | Standard Deviation 472 |
| DHA Capsule | Dietary Intake | 1388 kilocalorie | Standard Deviation 398 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1459 kilocalorie | Standard Deviation 439 |
| DHA Capsule | Dietary Intake | 1432 kilocalorie | Standard Deviation 423 |
Dietary Intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Time frame: 2 years
Population: Missing data due to attrition, missed appointments, refusals or questionable intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Dietary Intake | 1226 kilocalorie | Standard Deviation 384 |
| DHA Capsule | Dietary Intake | 1210 kilocalorie | Standard Deviation 439 |
Heart Rate
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Heart Rate | 90.4 Beats per minute (BPM) | Standard Deviation 10.7 |
| DHA Capsule | Heart Rate | 90.4 Beats per minute (BPM) | Standard Deviation 9.6 |
Heart Rate
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Heart Rate | 91.1 Beats per minute (BPM) | Standard Deviation 10.7 |
| DHA Capsule | Heart Rate | 91.1 Beats per minute (BPM) | Standard Deviation 9 |
Heart Rate
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Heart Rate | 92.6 Beats per minute (BPM) | Standard Deviation 9.9 |
| DHA Capsule | Heart Rate | 93.1 Beats per minute (BPM) | Standard Deviation 12 |
Heart Rate
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Heart Rate | 84.2 Beats per minute (BPM) | Standard Deviation 11 |
| DHA Capsule | Heart Rate | 85.4 Beats per minute (BPM) | Standard Deviation 10.8 |
Heart Rate
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Heart Rate | 87.9 Beats per minute (BPM) | Standard Deviation 12.4 |
| DHA Capsule | Heart Rate | 87.2 Beats per minute (BPM) | Standard Deviation 11 |
Systolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 6 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Systolic Blood Pressure | 99.6 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| DHA Capsule | Systolic Blood Pressure | 98.9 Millimeters of mercury (mmHg) | Standard Deviation 7.7 |
Systolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Systolic Blood Pressure | 99.5 Millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| DHA Capsule | Systolic Blood Pressure | 98.2 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
Systolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Systolic Blood Pressure | 100.0 Millimeters of mercury (mmHg) | Standard Deviation 10.8 |
| DHA Capsule | Systolic Blood Pressure | 98.7 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
Systolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 4.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Systolic Blood Pressure | 101.0 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| DHA Capsule | Systolic Blood Pressure | 100.3 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
Systolic Blood Pressure
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Time frame: 5.5 years
Population: Missing data due to attrition, missed appointments or refusals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule | Systolic Blood Pressure | 102.1 Millimeters of mercury (mmHg) | Standard Deviation 8.1 |
| DHA Capsule | Systolic Blood Pressure | 103.5 Millimeters of mercury (mmHg) | Standard Deviation 9.1 |