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Kansas University DHA Outcome Study (KUDOS) Follow-Up

Kansas University DHA Outcome Study (KUDOS) Follow-Up

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487771
Enrollment
190
Registered
2015-07-01
Start date
2008-07-31
Completion date
2016-05-31
Last updated
2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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

DRUGDHA

600 mg DHA capsule

DRUGPlacebo Capsule

600 mg of Soybean Oil and Corn Oil, which does not contain any DHA

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Susan Carlson, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ36 MonthsThe 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 Test60 MonthsThe 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 Literacy42 MonthsThe 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 IQ36 MonthsThe 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

MeasureTime frameDescription
Adaptive Regulation Assessment36 MonthsThe 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

MeasureTime frameDescription
Systolic Blood Pressure4 yearsBiannually 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-age2 yearsBiannually 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 Rate4 yearsBiannually 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 Pressure4 yearsBiannually 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-Age2 yearsBiannually 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-age2 yearsBiannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Anthropometrics: Head Circumference-for-age2 yearsBiannually 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 Intake2 yearsBiannually 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

ArmCount
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
Total190

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up23
Overall StudyMoved out of area56
Overall StudyWithdrawal by Subject35

Baseline characteristics

CharacteristicPlacebo CapsuleDHA CapsuleTotal
Age, Continuous2.01 years
STANDARD_DEVIATION 0.03
2.01 years
STANDARD_DEVIATION 0.03
2.01 years
STANDARD_DEVIATION 0.03
Race/Ethnicity, Customized
Black
33 Participants33 Participants66 Participants
Race/Ethnicity, Customized
Hispanic
10 Participants9 Participants19 Participants
Race/Ethnicity, Customized
Not Black
58 Participants66 Participants124 Participants
Race/Ethnicity, Customized
Not Hispanic
81 Participants90 Participants171 Participants
Region of Enrollment
United States
91 Participants99 Participants190 Participants
Sex: Female, Male
Female
40 Participants55 Participants95 Participants
Sex: Female, Male
Male
51 Participants44 Participants95 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleCognitive Function Score - Peabody Picture Vocabulary Test101.07 units on a scaleStandard Deviation 14.92
DHA CapsuleCognitive Function Score - Peabody Picture Vocabulary Test102.35 units on a scaleStandard Deviation 15.33
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleCognitive Function Score - Test of Preschool Early Literacy92.99 units on a scaleStandard Deviation 18.76
DHA CapsuleCognitive Function Score - Test of Preschool Early Literacy95.08 units on a scaleStandard Deviation 18.8
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ98.78 units on a scaleStandard Deviation 15.43
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ98.75 units on a scaleStandard Deviation 15.75
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ97.52 units on a scaleStandard Deviation 15.32
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ99.72 units on a scaleStandard Deviation 16.1
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ100.67 units on a scaleStandard Deviation 14.7
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ102.21 units on a scaleStandard Deviation 14.02
Primary

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ99.30 units on a scaleStandard Deviation 15.31
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ100.13 units on a scaleStandard Deviation 16.13
Primary

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ100.98 units on a scaleStandard Deviation 14.22
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ101.10 units on a scaleStandard Deviation 16.51
Primary

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ101.53 units on a scaleStandard Deviation 14.2
DHA CapsuleWeschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ102.44 units on a scaleStandard Deviation 14.88
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo CapsuleAdaptive Regulation AssessmentExternalizing Problems50.10 T-scoresStandard Deviation 9.68
Placebo CapsuleAdaptive Regulation AssessmentInternalizing Problems46.80 T-scoresStandard Deviation 7.8
Placebo CapsuleAdaptive Regulation AssessmentBehavioral Symptoms48.99 T-scoresStandard Deviation 8.09
Placebo CapsuleAdaptive Regulation AssessmentAdaptive Skills51.80 T-scoresStandard Deviation 8.09
DHA CapsuleAdaptive Regulation AssessmentAdaptive Skills49.73 T-scoresStandard Deviation 9.77
DHA CapsuleAdaptive Regulation AssessmentExternalizing Problems49.37 T-scoresStandard Deviation 6.76
DHA CapsuleAdaptive Regulation AssessmentBehavioral Symptoms49.17 T-scoresStandard Deviation 6.72
DHA CapsuleAdaptive Regulation AssessmentInternalizing Problems45.96 T-scoresStandard Deviation 8.35
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo CapsuleAdaptive Regulation AssessmentExternalizing Problems48.17 T-scoresStandard Deviation 6.86
Placebo CapsuleAdaptive Regulation AssessmentInternalizing Problems49.31 T-scoresStandard Deviation 9.67
Placebo CapsuleAdaptive Regulation AssessmentBehavioral Symptoms47.99 T-scoresStandard Deviation 7.13
Placebo CapsuleAdaptive Regulation AssessmentAdaptive Skills54.00 T-scoresStandard Deviation 7.49
DHA CapsuleAdaptive Regulation AssessmentAdaptive Skills52.56 T-scoresStandard Deviation 7.23
DHA CapsuleAdaptive Regulation AssessmentExternalizing Problems49.11 T-scoresStandard Deviation 7.85
DHA CapsuleAdaptive Regulation AssessmentBehavioral Symptoms49.46 T-scoresStandard Deviation 6.85
DHA CapsuleAdaptive Regulation AssessmentInternalizing Problems49.10 T-scoresStandard Deviation 8.05
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo CapsuleAdaptive Regulation AssessmentExternalizing Problems48.87 T-scoresStandard Deviation 8.22
Placebo CapsuleAdaptive Regulation AssessmentInternalizing Problems47.30 T-scoresStandard Deviation 8.65
Placebo CapsuleAdaptive Regulation AssessmentBehavioral Symptoms49.42 T-scoresStandard Deviation 8.62
Placebo CapsuleAdaptive Regulation AssessmentAdaptive Skills50.15 T-scoresStandard Deviation 8.76
DHA CapsuleAdaptive Regulation AssessmentAdaptive Skills47.72 T-scoresStandard Deviation 8.4
DHA CapsuleAdaptive Regulation AssessmentExternalizing Problems50.08 T-scoresStandard Deviation 8.22
DHA CapsuleAdaptive Regulation AssessmentBehavioral Symptoms50.59 T-scoresStandard Deviation 7.2
DHA CapsuleAdaptive Regulation AssessmentInternalizing Problems47.46 T-scoresStandard Deviation 8.73
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo CapsuleAdaptive Regulation AssessmentExternalizing Problems48.94 T-scoresStandard Deviation 8.71
Placebo CapsuleAdaptive Regulation AssessmentInternalizing Problems49.99 T-scoresStandard Deviation 7.96
Placebo CapsuleAdaptive Regulation AssessmentBehavioral Symptoms50.17 T-scoresStandard Deviation 7.66
Placebo CapsuleAdaptive Regulation AssessmentAdaptive Skills52.09 T-scoresStandard Deviation 8.18
DHA CapsuleAdaptive Regulation AssessmentAdaptive Skills50.96 T-scoresStandard Deviation 8.13
DHA CapsuleAdaptive Regulation AssessmentExternalizing Problems50.43 T-scoresStandard Deviation 9.22
DHA CapsuleAdaptive Regulation AssessmentBehavioral Symptoms50.78 T-scoresStandard Deviation 8.19
DHA CapsuleAdaptive Regulation AssessmentInternalizing Problems49.21 T-scoresStandard Deviation 8.75
Post Hoc

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

ArmMeasureGroupValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body CompositionFat Mass4.89 Kilogram (kg)Standard Deviation 1.59
Placebo CapsuleAnthropometrics: Body CompositionFat Free Mass14.60 Kilogram (kg)Standard Deviation 2.31
DHA CapsuleAnthropometrics: Body CompositionFat Mass5.17 Kilogram (kg)Standard Deviation 1.66
DHA CapsuleAnthropometrics: Body CompositionFat Free Mass15.18 Kilogram (kg)Standard Deviation 2.1
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.65 Body mass index (kg/m2)Standard Deviation 1.37
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.92 Body mass index (kg/m2)Standard Deviation 1.27
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.27 Body mass index (kg/m2)Standard Deviation 1.83
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.58 Body mass index (kg/m2)Standard Deviation 1.97
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.57 Body mass index (kg/m2)Standard Deviation 2.51
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.81 Body mass index (kg/m2)Standard Deviation 2.27
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.46 Body mass index (kg/m2)Standard Deviation 2.22
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.68 Body mass index (kg/m2)Standard Deviation 1.95
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.12 Body mass index (kg/m2)Standard Deviation 1.51
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.49 Body mass index (kg/m2)Standard Deviation 1.74
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.18 Body mass index (kg/m2)Standard Deviation 1.38
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.56 Body mass index (kg/m2)Standard Deviation 1.46
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.21 Body mass index (kg/m2)Standard Deviation 1.36
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.57 Body mass index (kg/m2)Standard Deviation 1.32
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age16.44 Body mass index (kg/m2)Standard Deviation 1.33
DHA CapsuleAnthropometrics: Body Mass Index-for-age16.67 Body mass index (kg/m2)Standard Deviation 1.25
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Body Mass Index-for-age17.13 Body mass index (kg/m^2)Standard Deviation 1.53
DHA CapsuleAnthropometrics: Body Mass Index-for-age17.31 Body mass index (kg/m^2)Standard Deviation 1.28
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age51.04 Centimeters (cm)Standard Deviation 1.48
DHA CapsuleAnthropometrics: Head Circumference-for-age51.37 Centimeters (cm)Standard Deviation 1.48
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age48.40 Centimeters (cm)Standard Deviation 1.29
DHA CapsuleAnthropometrics: Head Circumference-for-age48.50 Centimeters (cm)Standard Deviation 1.38
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age49.18 Centimeters (cm)Standard Deviation 1.36
DHA CapsuleAnthropometrics: Head Circumference-for-age49.21 Centimeters (cm)Standard Deviation 1.37
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age49.64 Centimeters (cm)Standard Deviation 1.34
DHA CapsuleAnthropometrics: Head Circumference-for-age49.75 Centimeters (cm)Standard Deviation 1.34
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age50.05 Centimeters (cm)Standard Deviation 1.35
DHA CapsuleAnthropometrics: Head Circumference-for-age50.15 Centimeters (cm)Standard Deviation 1.28
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age50.47 Centimeters (cm)Standard Deviation 1.37
DHA CapsuleAnthropometrics: Head Circumference-for-age50.62 Centimeters (cm)Standard Deviation 1.33
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age50.78 Centimeters (cm)Standard Deviation 1.36
DHA CapsuleAnthropometrics: Head Circumference-for-age50.95 Centimeters (cm)Standard Deviation 1.42
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age51.48 Centimeters (cm)Standard Deviation 1.42
DHA CapsuleAnthropometrics: Head Circumference-for-age51.58 Centimeters (cm)Standard Deviation 1.42
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Head Circumference-for-age51.77 Centimeters (cm)Standard Deviation 1.51
DHA CapsuleAnthropometrics: Head Circumference-for-age51.93 Centimeters (cm)Standard Deviation 1.59
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age113.41 Centimeters (cm)Standard Deviation 4.39
DHA CapsuleAnthropometrics: Height-for-Age114.01 Centimeters (cm)Standard Deviation 4.34
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age110.03 Centimeters (cm)Standard Deviation 4.3
DHA CapsuleAnthropometrics: Height-for-Age110.58 Centimeters (cm)Standard Deviation 4.23
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age85.91 Centimeters (cm)Standard Deviation 3.42
DHA CapsuleAnthropometrics: Height-for-Age86.54 Centimeters (cm)Standard Deviation 3.09
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age106.39 Centimeters (cm)Standard Deviation 4.23
DHA CapsuleAnthropometrics: Height-for-Age107.11 Centimeters (cm)Standard Deviation 4.09
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age102.77 Centimeters (cm)Standard Deviation 3.82
DHA CapsuleAnthropometrics: Height-for-Age103.32 Centimeters (cm)Standard Deviation 3.91
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age116.76 Centimeters (cm)Standard Deviation 4.74
DHA CapsuleAnthropometrics: Height-for-Age117.22 Centimeters (cm)Standard Deviation 4.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age98.96 Centimeters (cm)Standard Deviation 3.79
DHA CapsuleAnthropometrics: Height-for-Age99.27 Centimeters (cm)Standard Deviation 3.58
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age94.90 Centimeters (cm)Standard Deviation 3.48
DHA CapsuleAnthropometrics: Height-for-Age95.29 Centimeters (cm)Standard Deviation 3.52
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Height-for-Age90.66 Centimeters (cm)Standard Deviation 3.1
DHA CapsuleAnthropometrics: Height-for-Age91.17 Centimeters (cm)Standard Deviation 3.69
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age22.68 Kilogram (kg)Standard Deviation 4.16
DHA CapsuleAnthropometrics: Weight-for-age23.14 Kilogram (kg)Standard Deviation 3.66
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age21.23 Kilogram (kg)Standard Deviation 3.5
DHA CapsuleAnthropometrics: Weight-for-age21.73 Kilogram (kg)Standard Deviation 3.18
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age19.75 Kilogram (kg)Standard Deviation 2.85
DHA CapsuleAnthropometrics: Weight-for-age20.33 Kilogram (kg)Standard Deviation 3.05
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age18.29 Kilogram (kg)Standard Deviation 2.38
DHA CapsuleAnthropometrics: Weight-for-age18.96 Kilogram (kg)Standard Deviation 2.55
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age17.13 Kilogram (kg)Standard Deviation 2.11
DHA CapsuleAnthropometrics: Weight-for-age17.71 Kilogram (kg)Standard Deviation 2.1
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age15.90 Kilogram (kg)Standard Deviation 1.91
DHA CapsuleAnthropometrics: Weight-for-age16.36 Kilogram (kg)Standard Deviation 1.85
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age14.83 Kilogram (kg)Standard Deviation 1.76
DHA CapsuleAnthropometrics: Weight-for-age15.16 Kilogram (kg)Standard Deviation 1.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age12.66 Kilogram (kg)Standard Deviation 1.51
DHA CapsuleAnthropometrics: Weight-for-age12.99 Kilogram (kg)Standard Deviation 1.44
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleAnthropometrics: Weight-for-age13.70 Kilogram (kg)Standard Deviation 1.66
DHA CapsuleAnthropometrics: Weight-for-age14.08 Kilogram (kg)Standard Deviation 1.51
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDiastolic Blood Pressure62.5 Millimeters of mercury (mmHg)Standard Deviation 8
DHA CapsuleDiastolic Blood Pressure61.5 Millimeters of mercury (mmHg)Standard Deviation 7.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDiastolic Blood Pressure60.1 Millimeters of mercury (mmHg)Standard Deviation 6.1
DHA CapsuleDiastolic Blood Pressure59.0 Millimeters of mercury (mmHg)Standard Deviation 5.3
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDiastolic Blood Pressure58.9 Millimeters of mercury (mmHg)Standard Deviation 5.9
DHA CapsuleDiastolic Blood Pressure58.3 Millimeters of mercury (mmHg)Standard Deviation 7.7
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDiastolic Blood Pressure63.3 Millimeters of mercury (mmHg)Standard Deviation 9.5
DHA CapsuleDiastolic Blood Pressure61.0 Millimeters of mercury (mmHg)Standard Deviation 6.8
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDiastolic Blood Pressure62.1 Millimeters of mercury (mmHg)Standard Deviation 11.2
DHA CapsuleDiastolic Blood Pressure58.8 Millimeters of mercury (mmHg)Standard Deviation 7.7
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1412 kilocalorieStandard Deviation 380
DHA CapsuleDietary Intake1466 kilocalorieStandard Deviation 479
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1557 kilocalorieStandard Deviation 436
DHA CapsuleDietary Intake1532 kilocalorieStandard Deviation 458
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1655 kilocalorieStandard Deviation 487
DHA CapsuleDietary Intake1495 kilocalorieStandard Deviation 469
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1256 kilocalorieStandard Deviation 413
DHA CapsuleDietary Intake1234 kilocalorieStandard Deviation 396
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1364 kilocalorieStandard Deviation 418
DHA CapsuleDietary Intake1285 kilocalorieStandard Deviation 415
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1340 kilocalorieStandard Deviation 361
DHA CapsuleDietary Intake1275 kilocalorieStandard Deviation 407
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1468 kilocalorieStandard Deviation 472
DHA CapsuleDietary Intake1388 kilocalorieStandard Deviation 398
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1459 kilocalorieStandard Deviation 439
DHA CapsuleDietary Intake1432 kilocalorieStandard Deviation 423
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleDietary Intake1226 kilocalorieStandard Deviation 384
DHA CapsuleDietary Intake1210 kilocalorieStandard Deviation 439
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleHeart Rate90.4 Beats per minute (BPM)Standard Deviation 10.7
DHA CapsuleHeart Rate90.4 Beats per minute (BPM)Standard Deviation 9.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleHeart Rate91.1 Beats per minute (BPM)Standard Deviation 10.7
DHA CapsuleHeart Rate91.1 Beats per minute (BPM)Standard Deviation 9
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleHeart Rate92.6 Beats per minute (BPM)Standard Deviation 9.9
DHA CapsuleHeart Rate93.1 Beats per minute (BPM)Standard Deviation 12
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleHeart Rate84.2 Beats per minute (BPM)Standard Deviation 11
DHA CapsuleHeart Rate85.4 Beats per minute (BPM)Standard Deviation 10.8
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleHeart Rate87.9 Beats per minute (BPM)Standard Deviation 12.4
DHA CapsuleHeart Rate87.2 Beats per minute (BPM)Standard Deviation 11
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleSystolic Blood Pressure99.6 Millimeters of mercury (mmHg)Standard Deviation 8.1
DHA CapsuleSystolic Blood Pressure98.9 Millimeters of mercury (mmHg)Standard Deviation 7.7
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleSystolic Blood Pressure99.5 Millimeters of mercury (mmHg)Standard Deviation 7.1
DHA CapsuleSystolic Blood Pressure98.2 Millimeters of mercury (mmHg)Standard Deviation 8.3
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleSystolic Blood Pressure100.0 Millimeters of mercury (mmHg)Standard Deviation 10.8
DHA CapsuleSystolic Blood Pressure98.7 Millimeters of mercury (mmHg)Standard Deviation 8.3
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleSystolic Blood Pressure101.0 Millimeters of mercury (mmHg)Standard Deviation 8.7
DHA CapsuleSystolic Blood Pressure100.3 Millimeters of mercury (mmHg)Standard Deviation 7.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Placebo CapsuleSystolic Blood Pressure102.1 Millimeters of mercury (mmHg)Standard Deviation 8.1
DHA CapsuleSystolic Blood Pressure103.5 Millimeters of mercury (mmHg)Standard Deviation 9.1

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026