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

Centre for Chronic Disease Control, 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

NCT01580345

SERC/LS-451/2011

Details and patient eligibility

About

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.

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. This study would assess the effect of maternal DHA supplementation on:

New born anthropometry (birth weight, length and head circumference)
New born APGAR score

Enrollment

600 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 to 35 year old pregnant women (singleton) at <=20 weeks of gestation (calculated from the LMP by study physician).
Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk).
Willing to provide signed and dated informed consent.

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).