Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6
Information source: University of Oxford
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Village Children
Intervention: Vitamin A (Drug); Albendazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oxford Official(s) and/or principal investigator(s): Shally Awasthi, MD, Study Chair, Affiliation: King George Medical University, Lucknow
Summary
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.
Clinical Details
Official title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: childhood mortality rate at age 1-6
Secondary outcome: fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency
Eligibility
Minimum age: 1 Year.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
InclusionCriteria:
- Area of residence
Exclusion Criteria:
- NONE
Locations and Contacts
Shally Awasthi, Lucknow, Uttar Pradesh UP226 003, India
Additional Information
Starting date: January 1999
Last updated: October 27, 2005
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