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A Trial of Zinc and Micronutrients in Tanzanian Children

This study has been completed.
Sponsor:
Collaborator:
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

January 11, 2007
January 4, 2012
September 2000
October 2002   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence of diarrhea
  • respiratory tract infections
Complete list of historical versions of study NCT00421668 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Weight
  • Length/height
Not Provided
Not Provided
 
A Trial of Zinc and Micronutrients in Tanzanian Children
A Trial of Zinc and Micronutrients in Tanzanian Children

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diarrheal Illnesses
  • Respiratory Illness
  • Growth Faltering
  • Drug: Zinc
    zinc
  • Drug: Multivitamins
    Vitamins C, E, B1, B2, niacin, B6, folate and B12
  • Drug: Placebo
    Placebo
  • Experimental: Multivitamins
    Vitamins C, E, B1, B2, niacin, B6, folate, and B12
    Intervention: Drug: Multivitamins
  • Experimental: Multivitamins + Zinc
    Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc
    Interventions:
    • Drug: Zinc
    • Drug: Multivitamins
  • Experimental: Zinc
    zinc
    Intervention: Drug: Zinc
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2400
October 2002
October 2002   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00421668
HD048969
Yes
Harvard School of Public Health
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Christopher P Duggan, MD, MPH Harvard School of Public Health
Harvard School of Public Health
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP