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
• 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

• Acute Upper Respiratory Tract Infections
• Diarrhea
• Pneumonia
• Respiratory Tract Infections

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