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| Sponsors and Collaborators: |
Harvard School of Public Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00421668 |
Purpose
A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.
| Condition | Intervention | Phase |
|---|---|---|
|
Risk of Infectious Diseases and Growth Faltering |
Drug: Zinc Drug: Vitamins C, E, B1, B2, niacin, B6, folate and B12 Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Trial of Zinc and Micronutrients in Tanzanian Children |
| Estimated Enrollment: | 2400 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Multivitamins (B,C and E)
|
Drug: Vitamins C, E, B1, B2, niacin, B6, folate and B12 |
|
2: Experimental
Multivitamins (B, C, E) plus zinc
|
Drug: Zinc
zinc
Drug: Vitamins C, E, B1, B2, niacin, B6, folate and B12
|
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3: Experimental
zinc
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Drug: Zinc
zinc
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4: Placebo Comparator
placebo
|
Drug: placebo |
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.
Eligibility| Ages Eligible for Study: | 6 Weeks to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Tanzania | |
| Muhimbili Uinverstiy College of Health Sciences | Recruiting |
| Dar es Salaam, Tanzania | |
| Contact: karim Manji kmanji@muchs.ac.tz | |
| Principal Investigator: Karim Manji | |
| Principal Investigator: | Christopher P Duggan, MD, MPH | Harvard School of Public Health |
More Information
| Responsible Party: | Harvard School of Public Health ( Christopher Duggan, MD, MPH ) |
| Study ID Numbers: | HD048969 |
| Study First Received: | January 11, 2007 |
| Last Updated: | May 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00421668 |
| Health Authority: | United States: Institutional Review Board; Tanzania: Institutional Review Board; Tanzania: Tanzania Food and Drug Authority |
|
HIV Tanzania Micronutrients |
Infants/children Infectious Disease Growth faltering |
|
Folic Acid Nicotinic Acids HIV Infections Zinc |
Acquired Immunodeficiency Syndrome Niacin Ascorbic Acid |
|
Communicable Diseases Growth Substances Physiological Effects of Drugs Trace Elements |
Micronutrients Infection Pharmacologic Actions |
