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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT00228254

Collaborator

Corporacion Ecuatoriana de Biotecnologia (Other)

2,582

Enrollment

Locations

Duration (Months)

1291

Patients Per Site

24.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Diarrhea Acute Upper Respiratory Tract Infections	Drug: Zinc (12.5 mg/day) Drug: vitamin A 10,000 IU per week	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2000

Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Incidence of acute lower respiratory infection (pneumonia) []
Growth []

Secondary Outcome Measures

Additive or synergistic effects of zinc and vitamin A []
Incidence of diarrheal disease []
Incidence of other respiratory infections []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 36 Months

Sexes Eligible for Study:

All

Accepts 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