Study Results
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Basic Information
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COMPLETED
PHASE3
2387 participants
INTERVENTIONAL
2004-06-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Multivitamins
Vitamin E, Vitamin C, and Vitamin B complex
Multivitamins - vitamins B complex, C and E
Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
Placebo
Placebo
Placebo
Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months
Interventions
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Multivitamins - vitamins B complex, C and E
Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months
Placebo
Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months
Eligibility Criteria
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Inclusion Criteria
6 Weeks
24 Months
ALL
No
Sponsors
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Muhimbili University of Health and Allied Sciences
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Harvard School of Public Health
Principal Investigators
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Wafaie W Fawzi, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Muhimbili University of Health and Allied Sciences
Dar es Salaam, , Tanzania
Countries
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References
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Rees CA, Kisenge R, Manji KP, Liu E, Fawzi WW, Duggan CP. Identifying Infants and Young Children at Risk of Unplanned Hospital Admissions and Clinic Visits in Dar es Salaam, Tanzania. Pediatr Infect Dis J. 2020 Dec;39(12):e428-e434. doi: 10.1097/INF.0000000000002875.
Blakstad MM, Smith ER, Etheredge A, Locks LM, McDonald CM, Kupka R, Kisenge R, Aboud S, Bellinger D, Sudfeld CR, Fawzi WW, Manji K, Duggan CP. Nutritional, Socioeconomic, and Delivery Characteristics Are Associated with Neurodevelopment in Tanzanian Children. J Pediatr. 2019 Apr;207:71-79.e8. doi: 10.1016/j.jpeds.2018.10.066. Epub 2018 Dec 14.
Locks LM, Mwiru RS, Mtisi E, Manji KP, McDonald CM, Liu E, Kupka R, Kisenge R, Aboud S, Gosselin K, Gillman M, Gewirtz AT, Fawzi WW, Duggan CP. Infant Nutritional Status and Markers of Environmental Enteric Dysfunction are Associated with Midchildhood Anthropometry and Blood Pressure in Tanzania. J Pediatr. 2017 Aug;187:225-233.e1. doi: 10.1016/j.jpeds.2017.04.005. Epub 2017 May 9.
Locks LM, Manji KP, Kupka R, Liu E, Kisenge R, McDonald CM, Aboud S, Wang M, Fawzi WW, Duggan CP. High Burden of Morbidity and Mortality but Not Growth Failure in Infants Exposed to but Uninfected with Human Immunodeficiency Virus in Tanzania. J Pediatr. 2017 Jan;180:191-199.e2. doi: 10.1016/j.jpeds.2016.09.040. Epub 2016 Nov 7.
Sztam KA, Liu E, Manji KP, Kupka R, Kisenge R, Aboud S, Fawzi WW, Bosch RJ, Duggan CP. Maternal Antiretroviral Therapy Is Associated with Lower Risk of Diarrhea in Early Childhood. J Pediatr. 2016 Aug;175:54-60. doi: 10.1016/j.jpeds.2016.04.088. Epub 2016 May 28.
Manji KP, Duggan C, Liu E, Bosch R, Kisenge R, Aboud S, Kupka R, Fawzi WW. Exclusive Breast-feeding Protects against Mother-to-Child Transmission of HIV-1 through 12 Months of Age in Tanzania. J Trop Pediatr. 2016 Aug;62(4):301-7. doi: 10.1093/tropej/fmw012. Epub 2016 Mar 15.
Sudfeld CR, Duggan C, Aboud S, Kupka R, Manji KP, Kisenge R, Fawzi WW. Vitamin D status is associated with mortality, morbidity, and growth failure among a prospective cohort of HIV-infected and HIV-exposed Tanzanian infants. J Nutr. 2015 Jan;145(1):121-7. doi: 10.3945/jn.114.201566. Epub 2014 Nov 12.
Sudfeld CR, Duggan C, Histed A, Manji KP, Meydani SN, Aboud S, Wang M, Giovannucci EL, Fawzi WW. Effect of multivitamin supplementation on measles vaccine response among HIV-exposed uninfected Tanzanian infants. Clin Vaccine Immunol. 2013 Aug;20(8):1123-32. doi: 10.1128/CVI.00183-13. Epub 2013 May 29.
Kupka R, Manji KP, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW, Duggan C. Multivitamin supplements have no effect on growth of Tanzanian children born to HIV-infected mothers. J Nutr. 2013 May;143(5):722-7. doi: 10.3945/jn.112.170498. Epub 2013 Mar 20.
Duggan C, Manji KP, Kupka R, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW. Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2012 Dec;96(6):1437-46. doi: 10.3945/ajcn.112.044263. Epub 2012 Nov 7.
McDonald CM, Kupka R, Manji KP, Okuma J, Bosch RJ, Aboud S, Kisenge R, Spiegelman D, Fawzi WW, Duggan CP. Predictors of stunting, wasting and underweight among Tanzanian children born to HIV-infected women. Eur J Clin Nutr. 2012 Nov;66(11):1265-76. doi: 10.1038/ejcn.2012.136. Epub 2012 Oct 3.
Other Identifiers
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HD43688
Identifier Type: -
Identifier Source: org_study_id
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