Deworming and Vitamin A (DEVTA) Prepilot Study
Information source: King George's Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malnutrition; Worm Infestation; Under-Fives
Intervention: Albendazole (400 mg) and/or Vitamin a (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: King George's Medical University Official(s) and/or principal investigator(s):
Shally Awasthi, MD, DNB, Principal Investigator, Affiliation: Dept of Pediatrics, King George's Medical University, Lucknow, India
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.
Clinical Details
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 design: Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Change in weight in 2 years
Secondary outcome: Secondary: Weight and Height gain in underweight, stunted and wasted children
Eligibility
Minimum age: 1 Year.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Local residents
- Aged 1-5 years
- Informed written parental consent
Exclusion Criteria:
- Refusal to give consent
- prior enrollment in the study
Locations and Contacts
Lucknow Commission, Lucknow, Uttar Pradesh 226003, India
Additional Information
Starting date: April 1994
Ending date: December 1996
Last updated: November 6, 2006
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