A Trial of Zinc and Micronutrients in Tanzanian Children
Keywords
Coimriú
Cur síos
We propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among infants and young children in Tanzania. Infants born to HIV-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin, B6, folate and B12), micronutrients plus zinc, or a placebo given daily. Children will be followed at monthly clinic visits from age 6 weeks for 18 months. Data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometrics), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin, and blood smear for malaria. The primary outcomes will be the incidence of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and C-reactive protein. All children will receive a large periodic dose of vitamin A every 6 months as per standard of care in Tanzania.
Dátaí
Fíoraithe Deireanach: | 02/28/2017 |
Cuireadh isteach den chéad uair: | 01/10/2007 |
Clárú Measta Curtha isteach: | 01/10/2007 |
Arna chur suas ar dtús: | 01/11/2007 |
Nuashonrú Deireanach Curtha isteach: | 02/28/2017 |
Nuashonrú Deireanach Postáilte: | 03/02/2017 |
Dáta Tosaigh an Staidéir Iarbhír: | 08/31/2007 |
Dáta Críochnaithe Bunscoile Measta: | 09/30/2012 |
Dáta Críochnaithe an Staid Mheasta: | 09/30/2012 |
Coinníoll nó galar
Idirghabháil / cóireáil
Drug: Zinc
Drug: Multivitamins
Drug: Placebo
Céim
Grúpaí Láimhe
Lámh | Idirghabháil / cóireáil |
---|---|
Experimental: Multivitamins Vitamins C, E, B1, B2, niacin, B6, folate, and B12 | |
Experimental: Multivitamins + Zinc Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc | |
Experimental: Zinc zinc | |
Placebo Comparator: Placebo placebo | Drug: Placebo Placebo |
Critéir Incháilitheachta
Aois Incháilithe le haghaidh Staidéir | 6 Weeks Chun 6 Weeks |
Gnéas Incháilithe le haghaidh Staidéir | All |
Glacann Oibrithe Deonacha Sláintiúla | Sea |
Critéir | Inclusion Criteria: - Singleton, live born infants born to HIV- negative women - Mothers will need to have registered for pre-natal care before 34 weeks gestation - intend to stay in Dar es Salaam for until delivery and 18 months thereafter. Exclusion Criteria: - infants born with multiple congenital abnormalities |
Toradh
Bearta Toraidh Príomhúla
1. Incidence of diarrhea [from ages 6 weeks to 18 months]
2. respiratory tract infections [from ages 6 weeks to 18 months]
Bearta Torthaí Tánaisteacha
1. Weight gain [from age 6 weeks to 18 months]
2. Length/height gain [from age 6 weeks to 18 months]