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

Tufts University2,582 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,582

Conditions

Pneumonia Diarrhea Acute Upper Respiratory Tract Infections

Interventions

Zinc (12.5 mg/day)DRUG

vitamin A 10,000 IU per weekDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Tufts University School of Medicine

Boston, Massachusetts, United States

Corporacion Ecuatoriana de Biotecnologia

Quito, Pinchincha, Ecuador

Outcomes

Primary Outcomes

Incidence of acute lower respiratory infection (pneumonia)

Growth

Secondary Outcomes

Additive or synergistic effects of zinc and vitamin A

Incidence of diarrheal disease

Incidence of other respiratory infections

Data from ClinicalTrials.gov

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