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| Descriptive Information Fields | |||||
| Brief Title † | Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study | ||||
| Official Title † | Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Incidence of acute lower respiratory infection (pneumonia) Growth |
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| Secondary Outcome Measure † | Additive or synergistic effects of zinc and vitamin A Incidence of diarrheal disease Incidence of other respiratory infections |
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| Condition † | Pneumonia Diarrhea Acute Upper Respiratory Tract Infections |
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| Intervention † | Drug: Zinc (12.5 mg/day) Drug: vitamin A 10,000 IU per week |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 2582 | ||||
| Start Date † | January 2000 | ||||
| Completion Date | June 2004 | ||||
| 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 |
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| Gender | Both | ||||
| Ages | 6 Months to 36 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States, Ecuador | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00228254 | ||||
| Organization ID | R01-HD38327-01 | ||||
| Secondary IDs †† | R01-HD38327 | ||||
| Study Sponsor † | Tufts University | ||||
| Collaborators †† | Corporacion Ecuatoriana de Biotecnologia | ||||
| Investigators † |
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| Information Provided By | Tufts University | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 23, 2005 | ||||
| Last Updated Date | September 23, 2005 | ||||
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