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A Trial of Zinc and Micronutrients in Tanzanian Children

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00421668
First received: January 11, 2007
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  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
Diarrheal Illnesses
Respiratory Illness
Growth Faltering
 Drug: Zinc
Drug: Multivitamins
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Zinc and Micronutrients in Tanzanian Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Incidence of diarrhea [ Time Frame: from ages 6 weeks to 18 months ] [ Designated as safety issue: No ]
  • respiratory tract infections [ Time Frame: from ages 6 weeks to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight gain [ Time Frame: from age 6 weeks to 18 months ] [ Designated as safety issue: No ]
  • Length/height gain [ Time Frame: from age 6 weeks to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: September 2000
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate, and B12
 Drug: 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
 Drug: Zinc
zinc
Drug: Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Experimental: Zinc
zinc
 Drug: Zinc
zinc
Placebo Comparator: Placebo
placebo
 Drug: Placebo
Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421668

Locations
Tanzania
Muhimbili Uinverstiy College of Health Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Christopher P Duggan, MD, MPH Harvard School of Public Health
  More Information

No publications provided

Responsible Party: Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00421668     History of Changes
Other Study ID Numbers: HD048969
Study First Received: January 11, 2007
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:
HIV
Tanzania
Micronutrients
 Infants/children
Infectious Disease
Growth faltering

Additional relevant MeSH terms:
Micronutrients
Zinc
Trace Elements
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013