Phase 3
N=350
DHA Supplementation and Pregnancy Outcome
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00266825 ↗Enrolled (actual)
350
Serious AEs
15.5%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Total Fatty Acids by Weight — 4.7; 7.3; 4.8; 7.8 percentage of fatty acid
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DHA (Drug); Placebo capsule (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Susan Carlson, PhD
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Total Fatty Acids by Weight |
4.7; 7.3; 4.8; 7.8; 4.7; 6.2 | — |
| PRIMARY Gestational Age |
272.8; 275.7; 273.8; 275.9; 271.4; 275.2 | — |
| PRIMARY Birth Weight |
3187; 3359; 3282; 3489; 3060; 3110 | — |
| PRIMARY Birth Length |
49.0; 49.7; 49.2; 50.0; 48.6; 49.0 | — |
| SECONDARY Ponderal Index |
2.7; 2.7 | — |
| SECONDARY Gender of Babies |
54; 49; 46; 51 | — |
| SECONDARY Cord RBC-phospholipid-DHA |
5.9; 7.3 | — |
| SECONDARY Head Circumference |
33.7; 34.2 | — |
| SECONDARY Preterm Births |
8.8; 7.8 | — |
Summary
The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.
Eligibility Criteria
Inclusion Criteria
- Pregnant 8-20 wks at enrollment
- single fetus
- BMI <40
Exclusion Criteria
- diabetes (Type I, ii, GDM)
- hypertension (primary, PIH, preeclampsia/eclampsia)
Data sourced from ClinicalTrials.gov (NCT00266825). 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.