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Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2) — DHANI-2  

Pregnancy Clinical Trial

Official title:
Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)

Clinical Trial Summary

DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.

Clinical Trial 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. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03072277
Study type Interventional
Source Public Health Foundation of India
Contact
Status Completed
Phase Phase 3
Start date December 2015
Completion date December 2020
View Details
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