NCT01580345

Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.

Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India (DHANI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Centre for Chronic Disease Control, India · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.

Detailed description

A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. This study would assess the effect of maternal DHA supplementation on: 1. New born anthropometry (birth weight, length and head circumference) 2. New born APGAR score

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Docosa-hexaenoic acid (DHA)	400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through delivery.
DIETARY_SUPPLEMENT	Placebo	400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-06
• Completion: 2016-12-09
• First posted: 2012-04-19
• Last updated: 2017-02-23

Locations

1 site across 1 country: India