Pregnancy
Conditions
Keywords
DHA, Omega 3 fatty acid, Decosa hexaenoic acid, Pregnancy, Newborn outcome, Supplementation, Birth size, gestational age, India, Randomized controlled trial, RCT
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
Interventions
DIETARY_SUPPLEMENTDocosa-hexaenoic acid (DHA)
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.
DIETARY_SUPPLEMENTPlacebo
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.
Sponsors
Department of Science and Technology, Government of India
Jawaharlal Nehru Medical College
Centre for Chronic Disease Control, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Newborn anthropometry. | At delivery | Measures for new born anthropometry would include birth weight, length and head circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Outcome results
None listed