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

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

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.

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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome:

Incidence of acute lower respiratory infection (pneumonia)

Growth

Secondary outcome:

Additive or synergistic effects of zinc and vitamin A

Incidence 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.

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

Tufts University School of Medicine, Boston, Massachusetts 02111, United States

Corporacion Ecuatoriana de Biotecnologia, Quito, Pinchincha, Ecuador

Starting date: January 2000
Ending date: June 2004
Last updated: September 23, 2005