Pregnancy; Nutritional Diseases
Conditions
Keywords
Fat mass, Gestational weight gain, Fetal adipose tissue
Brief summary
The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.
Interventions
None listed
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants for this study are invited from the parent study, ADORE. Eligibility listed reflects criteria for the ADORE study. Inclusion Criteria: * Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA * Available by telephone
Exclusion criteria
* Expecting multiple infants * Gestational age at baseline \<12 weeks or \>20 weeks * Unable or unwilling to agree to consume capsules until delivery * Unwilling to discontinue use of another prenatal supplement with DHA that contains ≥ 200 mg DHA * Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Fat Mass (FM) | 24 months | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Fat Mass | 24 months | Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADORE- 200 mg/Day Participants enrolled in the ADORE study that were randomly assigned to the 200 mg/day group that consented to participate in ADORE-GAINS.
200 mg/day Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. | 126 |
| ADORE - 1000 mg/Day Participants enrolled in the ADORE study that were randomly assigned to the 1000 mg/day group that consented to participate in ADORE-GAINS.
1000 mg/day Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. | 128 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 17 |
Baseline characteristics
| Characteristic | ADORE- 200 mg/Day | ADORE - 1000 mg/Day | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 5.1 | 31.3 years STANDARD_DEVIATION 5.6 | 30.9 years STANDARD_DEVIATION 5.3 |
| Body Mass Index (BMI) | 28.2 kg/m^2 STANDARD_DEVIATION 6.9 | 29.1 kg/m^2 STANDARD_DEVIATION 8.1 | 28.7 kg/m^2 STANDARD_DEVIATION 7.5 |
| DHA mean % of RBC Total Fatty Acids | 6.5 percent of total fatty acids in RBC STANDARD_DEVIATION 1.7 | 6.1 percent of total fatty acids in RBC STANDARD_DEVIATION 1.6 | 6.3 percent of total fatty acids in RBC STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Maternal Race and Ethnicity American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Maternal Race and Ethnicity Asian | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Maternal Race and Ethnicity Black or African American | 13 Participants | 10 Participants | 23 Participants |
| Race/Ethnicity, Customized Maternal Race and Ethnicity Hispanic | 43 Participants | 53 Participants | 96 Participants |
| Race/Ethnicity, Customized Maternal Race and Ethnicity More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Maternal Race and Ethnicity White | 66 Participants | 59 Participants | 125 Participants |
| Sex: Female, Male Female | 126 Participants | 128 Participants | 254 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 126 |
| other Total, other adverse events | 0 / 124 | 0 / 126 |
| serious Total, serious adverse events | 0 / 124 | 0 / 126 |
Outcome results
Primary
Infant Fat Mass (FM)
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Time frame: 24 months
Population: Of the participants that completed the 24 month visit, many refused or were uncooperative during the DXA scan. And even a higher percentage were deemed unusable scans due to infant movement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 MG/DAY | Infant Fat Mass (FM) | 3050.7 g |
| 1000 MG/DAY | Infant Fat Mass (FM) | 3673.6 g |
Secondary
Central Fat Mass
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Time frame: 24 months
Population: Of the participants that completed the 24 month visit, many refused or were uncooperative during the DXA scan. And even a higher percentage were deemed unusable scans due to infant movement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 MG/DAY | Central Fat Mass | 1085.3 g |
| 1000 MG/DAY | Central Fat Mass | 1377.3 g |