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| Name | Class |
|---|---|
| Department of Science and Technology, Government of India | UNKNOWN |
| Jawaharlal Nehru Medical College | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docosa-hexaenoic Acid (DHA) | Active Comparator |
| |
| Placebo | Placebo Comparator | Corn-Soy Oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosa-hexaenoic acid (DHA) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Newborn anthropometry. | Measures for new born anthropometry would include birth weight, length and head circumference | At delivery |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shweta Khandelwal, PhD | Centre for Chronic Disease Control (CCDC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital | Belagavi | Karnataka | 590010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30077178 | Derived | Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5. |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | 400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery. |
|
|
| Unfavorable pregnancy outcomes | Still births, low birth weight babies and preterm babies | At delivery |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |