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Trial record 19 of 19 for:    " December 12, 2006":" January 12, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Trial of Zinc and Micronutrients in Tanzanian Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421668
First Posted: January 12, 2007
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Christopher Duggan, Harvard School of Public Health
  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
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Zinc and Micronutrients in Tanzanian Children

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

Primary Outcome Measures:
  • Incidence of diarrhea [ Time Frame: from ages 6 weeks to 18 months ]
  • respiratory tract infections [ Time Frame: from ages 6 weeks to 18 months ]

Secondary Outcome Measures:
  • Weight gain [ Time Frame: from age 6 weeks to 18 months ]
  • Length/height gain [ Time Frame: from age 6 weeks to 18 months ]

Enrollment: 2400
Study Start Date: September 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Duggan, Professor of Nutrition, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00421668     History of Changes
Other Study ID Numbers: HD048969
First Submitted: January 11, 2007
First Posted: January 12, 2007
Last Update Posted: March 3, 2017
Last Verified: March 2017

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

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