DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Tufts University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia; Diarrhea; Acute Upper Respiratory Tract Infections

Intervention: Zinc (12.5 mg/day) (Drug); vitamin A 10,000 IU per week (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Tufts University

Official(s) and/or principal investigator(s):
Jeffrey K Griffiths, MD MPH&TM, Principal Investigator, Affiliation: Tufts University School of Medicine

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Incidence of acute lower respiratory infection (pneumonia)

Growth

Secondary outcome:

Additive or synergistic effects of zinc and vitamin A

Incidence of diarrheal disease

Incidence of other respiratory infections

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

Minimum age: 6 Months. Maximum age: 36 Months. Gender(s): Both.

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

Locations and Contacts

Tufts University School of Medicine, Boston, Massachusetts 02111, United States

Corporacion Ecuatoriana de Biotecnologia, Quito, Pinchincha, Ecuador

Additional Information

Starting date: January 2000
Last updated: September 23, 2005

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017