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

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ClinicalTrials.gov Identifier: NCT00228254
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : September 28, 2005
Sponsor:
Collaborator:
Corporacion Ecuatoriana de Biotecnologia
Information provided by:
Tufts University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2582 participants
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 : January 2000
Estimated Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Vitamin A
U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of acute lower respiratory infection (pneumonia)
  2. Growth

Secondary Outcome Measures :
  1. Additive or synergistic effects of zinc and vitamin A
  2. Incidence of diarrheal disease
  3. Incidence of other respiratory infections


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228254


Locations
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Ecuador
Corporacion Ecuatoriana de Biotecnologia
Quito, Pinchincha, Ecuador
Sponsors and Collaborators
Tufts University
Corporacion Ecuatoriana de Biotecnologia
Investigators
Principal Investigator: Jeffrey K Griffiths, MD MPH&TM Tufts University School of Medicine

ClinicalTrials.gov Identifier: NCT00228254     History of Changes
Other Study ID Numbers: R01HD038327-01 ( U.S. NIH Grant/Contract )
R01HD038327 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: September 28, 2005
Last Verified: September 2005

Keywords provided by Tufts University:
acute respiratory infection
acute lower respiratory infection
diarrhea

Additional relevant MeSH terms:
Infection
Pneumonia
Diarrhea
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Vitamins
Vitamin A
Zinc
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents