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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Docosa-hexaenoic acid (DHA)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docosa-hexaenoic Acid (DHA)<br> | Dietary Supplement: Docosa-hexaenoic acid (DHA)<br>* 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.<br>* Other names: Omega 3 fatty acid;|
| Placebo Comparator: Placebo<br>Corn-Soy Oil | Dietary Supplement: Placebo<br>* 400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.<br>* Other names: Corn/Soy oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn anthropometry. | Measures for new born anthropometry would include birth weight, length and head circumference | At delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, Omega 3 fatty acid, Decosa hexaenoic acid, Pregnancy, Newborn outcome, Supplementation, Birth size, gestational age, India, Randomized controlled trial, RCT