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

This study has been completed.

First Received: September 13, 2005 Last Updated: October 27, 2005 History of Changes

Sponsors and Collaborators:	University of Oxford United States Agency for International Development (USAID)
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00222547

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Deworming and Enhanced Vitamin A Supplementation DEVTA Project

Resource links provided by NLM:

Drug Information available for: Retinol Vitamin A Albendazole

U.S. FDA Resources

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, Uttar Pradesh
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

Study ID Numbers:	DEVTA
Study First Received:	September 13, 2005
Last Updated:	October 27, 2005
ClinicalTrials.gov Identifier:	NCT00222547 History of Changes
Health Authority:	India: Institutional Review Board

Study placed in the following topic categories:

Retinol
Anticarcinogenic Agents
Albendazole
Antioxidants
Retinol palmitate
Vitamin A

Vitamins
Tubulin Modulators
Trace Elements
Anthelmintics
Micronutrients
Antimitotic Agents

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Infective Agents
Antiprotozoal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiplatyhelmintic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Anthelmintics
Antimitotic Agents

Protective Agents
Pharmacologic Actions
Anticestodal Agents
Albendazole
Antiparasitic Agents
Retinol palmitate
Vitamin A
Vitamins
Therapeutic Uses
Tubulin Modulators
Micronutrients

ClinicalTrials.gov processed this record on July 02, 2009