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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

Page last updated: August 20, 2015

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