Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6

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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...

Brief Summary

Official Title: “Deworming and Enhanced Vitamin A Supplementation DEVTA Project”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

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 Investigator Information

Lead Investigator: University of Oxford Other

Overall Clinical Trial Officials and Contacts

Shally Awasthi, MD Study Chair King George Medical University, Lucknow  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00222547