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Completed

NCT Number: NCT00228254

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

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.

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Key information

Conditions

Pneumonia Acute Upper Respiratory Tract Infections Diarrhea Infections Lung Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Corporacion Ecuatoriana de Biotecnologia, Quito, Pinchincha, Ecuador

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc (12.5 mg/day)

Drug

vitamin A 10,000 IU per week

Drug

Primary outcomes

  1. Incidence of acute lower respiratory infection (pneumonia)

  2. Growth

Secondary outcomes

  1. Additive or synergistic effects of zinc and vitamin A

  2. Incidence of diarrheal disease

  3. Incidence of other respiratory infections

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Corporacion Ecuatoriana de Biotecnologia

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
Sep 28, 2005
Registry last updated
Sep 28, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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