Trial Outcomes & Findings for Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation (NCT NCT03310983)
NCT ID: NCT03310983
Last Updated: 2024-10-08
Results Overview
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Recruitment status
COMPLETED
Target enrollment
254 participants
Primary outcome timeframe
24 months
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
200 MG/DAY
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
1000 MG/DAY
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
128
|
|
Overall Study
COMPLETED
|
111
|
111
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
200 MG/DAY
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
1000 MG/DAY
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
17
|
Baseline Characteristics
Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
Baseline characteristics by cohort
| Measure |
ADORE- 200 mg/Day
n=126 Participants
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.
|
ADORE - 1000 mg/Day
n=128 Participants
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.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · Black or African American
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · Hispanic
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · White
|
66 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maternal Race and Ethnicity · More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
DHA mean % of RBC Total Fatty Acids
|
6.5 percent of total fatty acids in RBC
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.1 percent of total fatty acids in RBC
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.3 percent of total fatty acids in RBC
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.2 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 8.1 • n=7 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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.
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Outcome measures
| Measure |
200 MG/DAY
n=31 Participants
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
1000 MG/DAY
n=28 Participants
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
|---|---|---|
|
Infant Fat Mass (FM)
|
3050.7 g
Interval 2697.3 to 3404.1
|
3673.6 g
Interval 3248.6 to 4098.7
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
Difference in FM in offspring exposed to high vs. low DHA and excessive vs. non-excessive GWG
Outcome measures
| Measure |
200 MG/DAY
n=31 Participants
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
1000 MG/DAY
n=28 Participants
Docosahexaenoic acid: The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
|
|---|---|---|
|
Central Fat Mass
|
1085.3 g
Interval 934.3 to 1236.2
|
1377.3 g
Interval 1195.8 to 1558.8
|
Adverse Events
200 MG/DAY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1000 MG/DAY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place