Effect of Docosa-hexaenoic Acid (DHA) Supplementation During Pregnancy on Newborn Outcome in India (DHANI_RCT)
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Purpose
Low birth weight and preterm birth-the leading causes of neonatal morbidity and mortality will be prevented by Docosa hexaenoic acid(DHA-omega 3 fatty acid)during pregnancy (from 12 - <16 weeks of gestation through delivery)
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy |
Dietary Supplement: Docosa-hexaenoic acid (DHA) Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Effect of Docosa-hexaenoic Acid (DHA) Supplementation During Pregnancy on Newborn Outcomes in India - the DHANI Randomized Controlled Trial. |
- Birth Weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Gestational Age [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Head circumference of the baby [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Crown-heel length [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- APGAR score [ Time Frame: At delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Docosa-hexaenoic Acid (DHA)
Dietary Supplement : DHA 400 mg/d of docosahexaenoic acid (DHA) will be given to the pregnant women from 12 - <16 weeks of gestation until delivery.
|
Dietary Supplement: Docosa-hexaenoic acid (DHA)
400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group)from 12 - <16 weeks of gestation until delivery.
Other Names:
|
|
Placebo Comparator: Corn/Soy oil
400 mg of placebo (corn/soy oil) will be given to the pregnant women from 12 - <16 weeks of gestation until delivery.
|
Dietary Supplement: Placebo
400 mg of placebo (corn/soy oil) will be given to the pregnant women from 12 - <16 weeks of gestation until delivery.
Other Name: Corn/Soy oil
|
Detailed Description:
Birth weight is a key indicator of the health trajectory of a child. In addition to being an intrinsic endpoint, low birth weight (LBW) is associated with increased risk of numerous adverse health outcomes in childhood and adulthood. One third of Indian children are born with low birth weight (NFHS-3, 2005-6). Mothers in deprived socio-economic conditions frequently have inadequate nutrition and consequently deliver LBW infants.
Dietary recommendations for pregnant women emphasize protein, energy, vitamin, and mineral adequacy, but recent attention is also being received by dietary lipids, especially essential fatty acids (EFAs). In particular, the n-3 fatty acid, docosahexaenoic acid (DHA), synthesized from alpha-linolenic acid (ALA) and found preformed in oil-rich fish, breast-milk, and algae, is essential for membrane function and plays a key role in the development of the foetal brain and retina. The main dietary source of DHA is oily fish and unsupplemented vegetarian diets contain little and vegan diets contain virtually no DHA. Studies also indicate that Indian adults have been particularly omega-3 deficient. Mounting evidence and current interest points towards supplementation of novel nutrients- omega-3 fatty acids esp DHA during pregnancy to improve birth outcome- over and above the standard of care. In view of the described inconclusive evidence of improved birth outcome by DHA, we propose a supplementation RCT with either DHA or placebo in Indian pregnant women. Our project will provide evidence for broad-based improvements to two quintessential global public health problems- preterm and LBW deliveries. This study will be a collaborative effort between Centre for Chronic Disease Control (CCDC) and Jawaharlal Nehru Medical College (JNMC), Belgaum, Karnataka.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ≤35 y old pregnant women (singleton) at <16 weeks of gestation (calculated from the LMP by study physician).
- Willing to participate in the study and perform all measurements including anthropometry, dietary assessment and questionnaires.
- Informed consent signed by subject.
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).
Contacts and Locations| Contact: Shweta Khandelwal, PhD | 91-011- 49566000 | shweta@ccdcindia.org |
| India | |
| Jawaharlal Nehru Medical College | Not yet recruiting |
| Belgaum, Karnataka, India, 590010 | |
| Contact: B S Kodkany, MD +91-831-24094059 drkodkany@jnmc.edu | |
| Principal Investigator: B S Kodkany, MD | |
| Principal Investigator: | Shweta Khandelwal, PhD | Centre for Chronic Disease Control |
More Information
No publications provided
| Responsible Party: | Dr. Shweta Khandelwal, Assistant Professor, Centre for Chronic Disease Control, India |
| ClinicalTrials.gov Identifier: | NCT01580345 History of Changes |
| Other Study ID Numbers: | SERC/LS-451/2011 |
| Study First Received: | April 18, 2012 |
| Last Updated: | March 13, 2013 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Centre for Chronic Disease Control, India:
|
DHA Omega 3 fatty acid Decosa hexaenoic acid Pregnancy Newborn outcome Supplementation |
Birth size gestational age India Randomized controlled trial RCT |
ClinicalTrials.gov processed this record on May 23, 2013