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

NCT ID: NCT00228254

Last Updated: 2005-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia Diarrhea Acute Upper Respiratory Tract Infections

Keywords

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acute respiratory infection acute lower respiratory infection diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Zinc (12.5 mg/day)

Intervention Type DRUG

vitamin A 10,000 IU per week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Corporacion Ecuatoriana de Biotecnologia

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Principal Investigators

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Jeffrey K Griffiths, MD MPH&TM

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Medicine

Locations

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Tufts University School of Medicine

Boston, Massachusetts, United States

Site Status

Corporacion Ecuatoriana de Biotecnologia

Quito, Pinchincha, Ecuador

Site Status

Countries

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United States Ecuador

References

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Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

Reference Type DERIVED
PMID: 36994923 (View on PubMed)

Other Identifiers

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R01HD038327

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD038327-01

Identifier Type: NIH

Identifier Source: org_study_id

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