Deworming and Vitamin A (DEVTA) Prepilot Study

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396500
• Other study ID #: 01
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2006
• Last updated: November 6, 2006
• Start date: April 1994
• Est. completion date: December 1996

Study information

• Verified date: November 2006
• Source: King George's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: December 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Local residents

• Aged 1-5 years

• Informed written parental consent

Exclusion Criteria:

• Refusal to give consent

• prior enrollment in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Helminthiasis
• Malnutrition
• Under-Fives
• Worm Infestation

Intervention

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

Locations

Country	Name	City	State
India	Lucknow Commission	Lucknow	Uttar Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
King George's Medical University	United States Agency for International Development (USAID)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight in 2 years
Secondary	Secondary: Weight and Height gain in underweight, stunted and wasted children