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

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ClinicalTrials.gov Identifier: NCT00396500
Recruitment Status : Completed
First Posted : November 7, 2006
Last Update Posted : November 7, 2006
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
King George's Medical University

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 1994
Study Completion Date : December 1996

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Change in weight in 2 years

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


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396500     History of Changes
Other Study ID Numbers: 01
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: November 2006

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

Additional relevant MeSH terms:
Malnutrition
Parasitic Diseases
Helminthiasis
Nutrition Disorders
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