N/A
N=254
Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation
Pregnancy; Nutritional Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03310983 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Infant Fat Mass (FM) — 3050.7; 3673.6 g
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infant Fat Mass (FM) |
3050.7; 3673.6 | — |
| SECONDARY Central Fat Mass |
1085.3; 1377.3 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03310983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.