A Trial of Zinc and Micronutrients in Tanzanian Children - Full Text View

Sponsors and Collaborators:	Harvard School of Public Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00421668

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Trial of Zinc and Micronutrients in Tanzanian Children

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:	March 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Multivitamins: Experimental Vitamins C, E, B1, B2, niacin, B6, folate, and B12	Drug: Multivitamins Vitamins C, E, B1, B2, niacin, B6, folate and B12
Multivitamins + Zinc: Experimental 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
Zinc: Experimental zinc	Drug: Zinc zinc
Placebo: Placebo Comparator 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	Recruiting
Dar es Salaam, Tanzania
Contact: karim Manji kmanji@muchs.ac.tz
Principal Investigator: Karim Manji

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 ( Christopher Duggan, MD, MPH )
Study ID Numbers:	HD048969
Study First Received:	January 11, 2007
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00421668 History of Changes
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

Study placed in the following topic categories:

Niacinamide
Acquired Immunodeficiency Syndrome
Folate
Trace Elements
Folinic Acid
Vitamin B9
Nicotinamide
Folic Acid
Vitamin C

Nicotinic Acids
Vitamin B3
HIV Infections
Vitamins
Zinc
Micronutrients
Nicotinic Acid
Niacin
Ascorbic Acid

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Zinc

Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009