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

This study has been completed.
Sponsor:
Collaborator:
Corporacion Ecuatoriana de Biotecnologia
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00228254
First received: September 23, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 23, 2005
September 23, 2005
January 2000
Not Provided
  • Incidence of acute lower respiratory infection (pneumonia)
  • Growth
Same as current
No Changes Posted
  • Additive or synergistic effects of zinc and vitamin A
  • Incidence of diarrheal disease
  • Incidence of other respiratory infections
Same as current
Not Provided
Not Provided
 
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Pneumonia
  • Diarrhea
  • Acute Upper Respiratory Tract Infections
  • Drug: Zinc (12.5 mg/day)
  • Drug: vitamin A 10,000 IU per week
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2582
June 2004
Not Provided

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

Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Ecuador
 
NCT00228254
R01-HD38327-01, R01-HD38327
Not Provided
Not Provided
Tufts University
Corporacion Ecuatoriana de Biotecnologia
Principal Investigator: Jeffrey K Griffiths, MD MPH&TM Tufts University School of Medicine
Tufts University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP