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NCT00228254 Clinical Trial

Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Pneumonia Clinical Trial

Official title:
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00228254
Other study ID # R01HD038327-01
Secondary ID R01HD038327
Status Completed
Phase Phase 4
First received September 23, 2005
Last updated September 23, 2005
Start date January 2000
Est. completion date June 2004

Study information
Verified date September 2005
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.

Description:

The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of ~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.

Recruitment information / eligibility
Status Completed
Enrollment 2582
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 36 Months
Eligibility Inclusion Criteria:

Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight < or = to 60% of expected weight

Exclusion Criteria:

Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Zinc (12.5 mg/day)

• vitamin A 10,000 IU per week

Locations
Country Name City State
Ecuador Corporacion Ecuatoriana de Biotecnologia Quito Pinchincha
United States Tufts University School of Medicine Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Tufts University Corporacion Ecuatoriana de Biotecnologia

Countries where clinical trial is conducted

United States,  Ecuador, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of acute lower respiratory infection (pneumonia)
Primary Growth
Secondary Additive or synergistic effects of zinc and vitamin A
Secondary Incidence of diarrheal disease
Secondary Incidence of other respiratory infections
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