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Completed

NCT Number: NCT00421668

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.

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Key information

Conditions

Diarrheal Illnesses Communicable Diseases Disease Attributes Growth Faltering Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Illness

Age range

6 week–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Muhimbili Uinverstiy College of Health Sciences

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Drug

zinc

Multivitamins

Drug

Vitamins C, E, B1, B2, niacin, B6, folate and B12

Placebo

Drug

Placebo

Primary outcomes

  1. Incidence of diarrhea

    Time frame: from ages 6 weeks to 18 months

  2. respiratory tract infections

    Time frame: from ages 6 weeks to 18 months

Secondary outcomes

  1. Weight gain

    Time frame: from age 6 weeks to 18 months

  2. Length/height gain

    Time frame: from age 6 weeks to 18 months

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2007
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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