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

Tufts University logo

Tufts University

Status and phase

Completed
Phase 4

Conditions

Diarrhea
Acute Upper Respiratory Tract Infections
Pneumonia

Treatments

Drug: Zinc (12.5 mg/day)
Drug: vitamin A 10,000 IU per week

Study type

Interventional

Funder types

Other

Identifiers

NCT00228254
R01HD038327-01
R01HD038327 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6 to 36 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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