A Trial of Zinc and Micronutrients in Tanzanian Children

March 1, 2017 updated by: Christopher Duggan, Harvard School of Public Health (HSPH)
A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili Uinverstiy College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: Placebo
Placebo
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: Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
Drug: Zinc
zinc
Experimental: Zinc
zinc
Drug: Zinc
zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of diarrhea
Time Frame: from ages 6 weeks to 18 months
from ages 6 weeks to 18 months
respiratory tract infections
Time Frame: from ages 6 weeks to 18 months
from ages 6 weeks to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: from age 6 weeks to 18 months
from age 6 weeks to 18 months
Length/height gain
Time Frame: from age 6 weeks to 18 months
from age 6 weeks to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

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 (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 12, 2007

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HD048969

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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