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

Phase 4

Completed

• Conditions: Pneumonia; Diarrhea; Acute Upper Respiratory Tract Infections

• Registration Number: NCT00228254
• Lead Sponsor: Tufts University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-01
• Study Completion: 2004-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Last Update Submitted: 2005-09-23
• Study First Posted: 2005-09-28
• Last Update Posted: 2005-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2582

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Incidence of acute lower respiratory infection (pneumonia)
Growth

Secondary Outcome Measures

Name	Time	Method
Additive or synergistic effects of zinc and vitamin A
Incidence of diarrheal disease
Incidence of other respiratory infections

Trial Locations

Locations (2)

Tufts University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Corporacion Ecuatoriana de Biotecnologia; 🇪🇨 Quito, Pinchincha, Ecuador