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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228254

Enrollment

2582

Registered

2005-09-28

Start date

2000-01-31

Completion date

2004-06-30

Last updated

2005-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Upper Respiratory Tract Infections, Diarrhea, Pneumonia

Keywords

acute respiratory infection, acute lower respiratory infection, diarrhea

Brief summary

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

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.

Interventions

DRUGZinc (12.5 mg/day)

DRUGvitamin A 10,000 IU per week

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 36 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of acute lower respiratory infection (pneumonia)	—
Growth	—

Secondary

Measure	Time frame
Additive or synergistic effects of zinc and vitamin A	—
Incidence of diarrheal disease	—
Incidence of other respiratory infections	—

Countries

Ecuador, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026