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Sponsors and Collaborators: |
King George's Medical University US Agency for International Development |
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Information provided by: | King George's Medical University |
ClinicalTrials.gov Identifier: | NCT00396500 |
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 |
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Malnutrition Worm Infestation Under-Fives |
Drug: Albendazole (400 mg) and/or Vitamin a |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | 1 Year to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Uttar Pradesh | |
Lucknow Commission | |
Lucknow, Uttar Pradesh, India, 226003 |
Principal Investigator: | Shally Awasthi, MD, DNB | Dept of Pediatrics, King George's Medical University, Lucknow, India |
Study ID Numbers: | 01 |
Study First Received: | November 4, 2006 |
Last Updated: | November 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00396500 |
Health Authority: | India: Institutional Review Board |
Deworming Malnutrition children Community India |
Albendazole Malnutrition Retinol palmitate Vitamin A |
Nutrition Disorders Parasitic Diseases Helminthiasis |
Anticarcinogenic Agents Anti-Infective Agents Antiprotozoal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antiplatyhelmintic Agents Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators |
Anthelmintics Antimitotic Agents Protective Agents Pharmacologic Actions Anticestodal Agents Antiparasitic Agents Vitamins Therapeutic Uses Tubulin Modulators Micronutrients |