Trial record 1 of 1 for:    NCT00396500
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Deworming and Vitamin A (DEVTA) Prepilot Study

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
King George's Medical University
ClinicalTrials.gov Identifier:
NCT00396500
First received: November 4, 2006
Last updated: November 6, 2006
Last verified: November 2006

November 4, 2006
November 6, 2006
April 1994
Not Provided
Change in weight in 2 years
Same as current
Complete list of historical versions of study NCT00396500 on ClinicalTrials.gov Archive Site
Secondary: Weight and Height gain in underweight, stunted and wasted children
Same as current
Not Provided
Not Provided
 
Deworming and Vitamin A (DEVTA) Prepilot Study
To Assess the Effectiveness of Six-Monthly Deworming With Vitamin A Administration on Growth in 1-5 Year Old Children in the Urban Slums of Lucknow

Background. More than a third of the world’s population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Malnutrition
  • Worm Infestation
  • Under-Fives
Drug: Albendazole (400 mg) and/or Vitamin a
Not Provided
Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e223.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
December 1996
Not Provided

Inclusion Criteria:

  • Local residents
  • Aged 1-5 years
  • Informed written parental consent

Exclusion Criteria:

  • Refusal to give consent
  • prior enrollment in the study
Both
1 Year to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00396500
01
Not Provided
Not Provided
King George's Medical University
United States Agency for International Development (USAID)
Principal Investigator: Shally Awasthi, MD, DNB Dept of Pediatrics, King George's Medical University, Lucknow, India
King George's Medical University
November 2006

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