A Trial of Zinc and Micronutrients in Tanzanian Children

Respiratory Illness Clinical Trial

Official title:

A Trial of Zinc and Micronutrients in Tanzanian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421668
• Other study ID #: HD048969
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2007
• Last updated: March 1, 2017
• Start date: September 2007
• Est. completion date: October 2012

Study information

• Verified date: March 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrheal Illnesses
• Growth Faltering
• Respiratory Illness

Intervention

Drug:
• Zinc
zinc
• Multivitamins
Vitamins C, E, B1, B2, niacin, B6, folate and B12
• Placebo
Placebo

Locations

Country	Name	City	State
Tanzania	Muhimbili Uinverstiy College of Health Sciences	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diarrhea		from ages 6 weeks to 18 months
Primary	respiratory tract infections		from ages 6 weeks to 18 months
Secondary	Weight gain		from age 6 weeks to 18 months
Secondary	Length/height gain		from age 6 weeks to 18 months