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

Phase 3

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Docosa-hexaenoic acid (DHA); Dietary Supplement: Placebo

• Registration Number: NCT01580345
• Lead Sponsor: Centre for Chronic Disease Control, India

Brief 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

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Study Start: 2015-12
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docosa-hexaenoic Acid (DHA)	Docosa-hexaenoic acid (DHA)	-
Placebo	Placebo	Corn-Soy Oil

Primary Outcome Measures

Name	Time	Method
Newborn anthropometry.	At delivery	Measures for new born anthropometry would include birth weight, length and head circumference

Secondary Outcome Measures

Name	Time	Method
Gestational age	At delivery
New born APGAR Score	At delivery (1 min and 5 mins)	APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores
Unfavorable pregnancy outcomes	At delivery	Still births, low birth weight babies and preterm babies

Trial Locations

Locations (1)

KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital; 🇮🇳 Belgaum, Karnataka, India