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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 27, 2005

Start Date ^ICMJE

January 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

childhood mortality rate at age 1-6

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00222547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Deworming and Enhanced Vitamin A Supplementation DEVTA Project

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Village Children

Intervention ^ICMJE

Drug: Vitamin A
Drug: Albendazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

720000

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

InclusionCriteria:

Area of residence

Exclusion Criteria:

NONE

Gender

Both

Ages

1 Year to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00222547

Responsible Party

Study ID Numbers ^ICMJE

DEVTA

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

United States Agency for International Development (USAID)

Investigators ^ICMJE

Study Chair:

Shally Awasthi, MD

King George Medical University, Lucknow

Information Provided By

University of Oxford

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP