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| Sponsor: | Tufts University |
|---|---|
| Collaborator: |
Corporacion Ecuatoriana de Biotecnologia |
| Information provided by: | Tufts University |
| ClinicalTrials.gov Identifier: | NCT00228254 |
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 IV |
| 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 |
| Estimated Enrollment: | 2582 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | June 2004 |
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 |
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| United States, Massachusetts | |
| Tufts University School of Medicine | |
| Boston, Massachusetts, United States, 02111 | |
| Ecuador | |
| Corporacion Ecuatoriana de Biotecnologia | |
| Quito, Pinchincha, Ecuador | |
| Principal Investigator: | Jeffrey K Griffiths, MD MPH&TM | Tufts University School of Medicine |
More Information
| 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 |
|
acute respiratory infection acute lower respiratory infection diarrhea |
|
Diarrhea Pneumonia Respiratory Tract Infections Common Cold Signs and Symptoms, Digestive Signs and Symptoms Lung Diseases Respiratory Tract Diseases Infection Picornaviridae Infections RNA Virus Infections Virus Diseases Vitamin A Vitamins |
Zinc 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 Trace Elements |
