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

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ClinicalTrials.gov Identifier: NCT00222547
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 28, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Village Children Drug: Vitamin A Drug: Albendazole Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Study Start Date : January 1999
Estimated Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

InclusionCriteria:

  • Area of residence

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00222547     History of Changes
Other Study ID Numbers: DEVTA
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: February 2005

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