Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos...
Date First Received: September 13, 2005
Last Updated: October 27, 2005
Verified by: University of Oxford, February 2005
Clinical Trial Phase: Phase 4 | Start Date: January 1999
Overall Status: Completed
Estimated Enrollment: 720000
Brief Summary
Official Title: “Deworming and Enhanced Vitamin A Supplementation DEVTA Project”
Condition Keyword(s):
Intervention(s):
Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Vitamin A
- Drug: Albendazole
Outcome Measures for this Clinical Trial
Primary Measures
- childhood mortality rate at age 1-6
Secondary Measures
- fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency
Criteria for Participation in this Clinical Trial
InclusionCriteria:
- Area of residence
Exclusion Criteria:
- NONE
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 6 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Oxford
Overall Clinical Trial Officials and Contacts
Shally Awasthi, MD Study Chair King George Medical University, Lucknow
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00222547
Study ID Number: DEVTA
ClinicalTrials.gov Identifier: NCT00222547
Health Authority: India: Institutional Review Board
Clinical Trials Authorship and Review
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