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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00421668
Other study ID # HD048969
Secondary ID
Status Completed
Phase Phase 3
First received January 11, 2007
Last updated March 1, 2017
Start date September 2007
Est. completion date October 2012

Study information

Verified date March 2017
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 18 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zinc
zinc
Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Placebo
Placebo

Locations

Country Name City State
Tanzania Muhimbili Uinverstiy College of Health Sciences Dar es Salaam

Sponsors (2)

Lead Sponsor Collaborator
Harvard School of Public Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of diarrhea from ages 6 weeks to 18 months
Primary respiratory tract infections from ages 6 weeks to 18 months
Secondary Weight gain from age 6 weeks to 18 months
Secondary Length/height gain from age 6 weeks to 18 months
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