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Deworming and Vitamin A (DEVTA) Prepilot Study

NCT00396500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2006-11-07

No results posted yet for this study

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.

Conditions

  • Malnutrition
  • Worm Infestation
  • Under-Fives

Interventions

DRUG

Albendazole (400 mg) and/or Vitamin a

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • King George's Medical University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-04-30
Completion
1996-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396500 on ClinicalTrials.gov