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

History of Changes

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:

MedlinePlus related topics: Vitamin A

Drug Information available for: Retinol Vitamin A palmitate 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
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):

Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1478-86. doi: 10.1016/S0140-6736(12)62126-6. Epub 2013 Mar 14.

Awasthi S, Peto R, Read S, Clark S, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1469-77. doi: 10.1016/S0140-6736(12)62125-4. Epub 2013 Mar 14.

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 May 23, 2013

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