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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
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The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.
This is a randomized clinical trial conducted to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA. All women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivitamins-Single RDA | Experimental | Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA) |
|
| Multivitamins-Multiples of RDA | Active Comparator | Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamins-Multiples of RDA | Dietary Supplement | 20 mg B1, 20 mg B2, 25 mg B6, 50 mcg B12, 100 mg niacin, 500 mg C, 30 mg E, 0.8 mg folic acid taken orally once per day until 6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Low birthweight (< 2500 g) | Delivery | |
| Pre-term birth (< 36 weeks gestation) | Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week |
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Inclusion Criteria:
- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
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| Name | Affiliation | Role |
|---|---|---|
| Wafaie W. Fawzi, MD,DrPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard School of Public Health | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19939985 | Result | Kawai K, Kupka R, Mugusi F, Aboud S, Okuma J, Villamor E, Spiegelman D, Fawzi WW. A randomized trial to determine the optimal dosage of multivitamin supplements to reduce adverse pregnancy outcomes among HIV-infected women in Tanzania. Am J Clin Nutr. 2010 Feb;91(2):391-7. doi: 10.3945/ajcn.2009.28483. Epub 2009 Nov 25. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Multivitamins-Single RDA | Dietary Supplement | 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 50 mcg B12, 100 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid taken orally once per day until 6 weeks after delivery |
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |