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”

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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Albendazole (400 mg) and/or Vitamin a

Primary Measures

• Change in weight in 2 years

Secondary Measures

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

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to give consent
• prior enrollment in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: King George's Medical University

Overall Clinical Trial Officials and Contacts

Shally Awasthi, MD, DNB Principal Investigator Dept of Pediatrics, King George's Medical University, Lucknow, India  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00396500

Study ID Number: 01

ClinicalTrials.gov Identifier: NCT00396500

Health Authority: India: Institutional Review Board