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
  Purpose

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.


Condition Intervention Phase
Malnutrition
Worm Infestation
Under-Fives
Drug: Albendazole (400 mg) and/or Vitamin a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by King George's Medical University:

Primary Outcome Measures:
  • Change in weight in 2 years

Secondary Outcome Measures:
  • Secondary: Weight and Height gain in underweight, stunted and wasted children

Estimated Enrollment: 4000
Study Start Date: April 1994
Estimated Study Completion Date: December 1996
  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to give consent
  • prior enrollment in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396500

Locations
India
Lucknow Commission
Lucknow, Uttar Pradesh, India, 226003
Sponsors and Collaborators
King George's Medical University
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Shally Awasthi, MD, DNB Dept of Pediatrics, King George's Medical University, Lucknow, India
  More Information

No publications provided by King George's Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396500     History of Changes
Other Study ID Numbers: 01
Study First Received: November 4, 2006
Last Updated: November 6, 2006
Health Authority: India: Institutional Review Board

Keywords provided by King George's Medical University:
Deworming
Malnutrition
children
Community
India

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases
Malnutrition
Nutrition Disorders
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 April 16, 2014