DHA Supplementation and Pregnancy Outcome

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: 300 mg DHA; Dietary Supplement: 600 mg DHA; Dietary Supplement: Placebo

• Registration Number: NCT02219399
• Lead Sponsor: Colorado State University

Brief Summary

Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Detailed Description

This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-01
• Study Completion: 2014-01
• Study First Submitted: 2014-06-09
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-15
• Last Update Submitted: 2014-08-15
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 871

Inclusion Criteria

• singleton pregnancy
• 18 years of age or older

Exclusion Criteria

• cervical incompetence
• presence of cervical cerclage
• placenta previa
• intrauterine infection
• known substance abuse
• multiple fetuses
• current pre-eclampsia
• preexisting diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 mg DHA	300 mg DHA	300 mg DHA
600 mg DHA	600 mg DHA	600 mg DHA
Placebo	Placebo	olive oil or high oleic acid sunflower oil placebo

Primary Outcome Measures

Name	Time	Method
Gestational Length	13 weeks	Length of gestation as measured by Last menstrual period method and US
Cognitive Development	12 months	Bayley's Scales of Infant Development measured at 12 months of age

Secondary Outcome Measures

Name	Time	Method
Infant birth length	13 weeks	self-explanatory
Infant Growth Velocity	2 months to 4 months of age	Change in infant length and weight from 2 to 4 months of age
Infant birth weight	13 weeks	self-explanatory
Infant head circumference at birth	13 weeks	self-explanatory

Trial Locations

Locations (2)

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States

Denver Health Hospitals and Clinics; 🇺🇸 Denver, Colorado, United States