Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Information source: Tufts University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia; Diarrhea; Acute Upper Respiratory Tract Infections
Intervention: Zinc (12.5 mg/day) (Drug); vitamin A 10,000 IU per week (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tufts University Official(s) and/or principal investigator(s): Jeffrey K Griffiths, MD MPH&TM, Principal Investigator, Affiliation: Tufts University School of Medicine
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.
Clinical Details
Official title: Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: Incidence of acute lower respiratory infection (pneumonia)Growth
Secondary outcome: Additive or synergistic effects of zinc and vitamin AIncidence of diarrheal disease Incidence of other respiratory 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.
Eligibility
Minimum age: 6 Months.
Maximum age: 36 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tufts University School of Medicine, Boston, Massachusetts 02111, United States
Corporacion Ecuatoriana de Biotecnologia, Quito, Pinchincha, Ecuador
Additional Information
Starting date: January 2000
Last updated: September 23, 2005
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