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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

Resource links provided by NLM:


Further study details as provided by Tufts University:

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

Estimated Enrollment: 2582
Study Start Date: January 2000
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00228254     History of Changes
Other Study ID Numbers: R01-HD38327-01, R01-HD38327
Study First Received: September 23, 2005
Last Updated: September 23, 2005
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 19, 2014