Back to resultsVitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Primary Purpose
Pneumonia, Diarrhea, Acute Upper Respiratory Tract Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Zinc (12.5 mg/day)
vitamin A 10,000 IU per week
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia focused on measuring acute respiratory infection, acute lower respiratory infection, diarrhea
Eligibility Criteria
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
Sites / Locations
- Tufts University School of Medicine
- Corporacion Ecuatoriana de Biotecnologia
Outcomes
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
Full Information
NCT ID
NCT00228254
First Posted
September 23, 2005
Last Updated
September 23, 2005
Sponsor
Tufts University
Collaborators
Corporacion Ecuatoriana de Biotecnologia
1. Study Identification
Unique Protocol Identification Number
NCT00228254
Brief Title
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Official Title
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tufts University
Collaborators
Corporacion Ecuatoriana de Biotecnologia
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Diarrhea, Acute Upper Respiratory Tract Infections
Keywords
acute respiratory infection, acute lower respiratory infection, diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
2582 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zinc (12.5 mg/day)
Intervention Type
Drug
Intervention Name(s)
vitamin A 10,000 IU per week
Primary Outcome Measure Information:
Title
Incidence of acute lower respiratory infection (pneumonia)
Title
Growth
Secondary Outcome Measure Information:
Title
Additive or synergistic effects of zinc and vitamin A
Title
Incidence of diarrheal disease
Title
Incidence of other respiratory infections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey K Griffiths, MD MPH&TM
Organizational Affiliation
Tufts University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Corporacion Ecuatoriana de Biotecnologia
City
Quito
State/Province
Pinchincha
Country
Ecuador
12. IPD Sharing Statement
Learn more about this trial
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
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