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

Public Health Foundation of India

Status and phase

Completed

Phase 3

Conditions

Pregnancy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Docosa Hexaenoic Acid (DHA)

Study type

Interventional

Funder types

Other

Identifiers

NCT03072277

IA/CPHE/14/1/501498

Details and patient eligibility

About

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.

Full 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).

Enrollment

957 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
18-35 years
Hb > 7 g/dL
Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (<140mg/dL)
No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
High risk pregnancy (short stature**, molar pregnancy++, HBsAg positive, as advised by physicians)
- <143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.

Exclusion criteria

Women allergic (if aware) to any of the test products.
Women at high risk for hemorrhagic bleeding, clotting (if aware).
Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).