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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
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.
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.
KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital
Belagavi, Karnataka, India
Newborn anthropometry.
Measures for new born anthropometry would include birth weight, length and head circumference
Time frame: At delivery
Gestational age
Time frame: At delivery
New born APGAR Score
APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores
Time frame: At delivery (1 min and 5 mins)
Unfavorable pregnancy outcomes
Still births, low birth weight babies and preterm babies
Time frame: At delivery
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