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Phase 3 Completed N=350 Randomized Double-blind Treatment

DHA Supplementation and Pregnancy Outcome

Source: ClinicalTrials.gov NCT00266825 ↗
Enrolled (actual)
350
Serious AEs
15.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Total Fatty Acids by Weight — 4.7; 7.3; 4.8; 7.8 percentage of fatty acid

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.

Outcome Measures

OutcomeResultp-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

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)
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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