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

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00222547
First received: September 13, 2005
Last updated: October 27, 2005
Last verified: February 2005
  Purpose

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.


Condition Intervention Phase
Village Children
Drug: Vitamin A
Drug: Albendazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • childhood mortality rate at age 1-6

Secondary Outcome Measures:
  • fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency

Estimated Enrollment: 720000
Study Start Date: January 1999
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

InclusionCriteria:

  • Area of residence

Exclusion Criteria:

  • NONE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222547

Locations
India
Shally Awasthi
Lucknow, Uttar Pradesh, India, UP226 003
Sponsors and Collaborators
University of Oxford
United States Agency for International Development (USAID)
Investigators
Study Chair: Shally Awasthi, MD King George Medical University, Lucknow
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00222547     History of Changes
Other Study ID Numbers: DEVTA
Study First Received: September 13, 2005
Last Updated: October 27, 2005
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Albendazole
Vitamin A
Vitamins
Retinol palmitate
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Protective Agents
Anticarcinogenic Agents

ClinicalTrials.gov processed this record on April 15, 2014