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Deworming and Vitamin A (DEVTA) Prepilot Study

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00396500
Enrollment
4000
Registered
2006-11-07
Start date
1994-04-30
Completion date
1996-12-31
Last updated
2006-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Under-Fives, Worm Infestation

Keywords

Deworming, Malnutrition, children, Community, India

Brief 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.

Interventions

DRUGAlbendazole (400 mg) and/or Vitamin a

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Refusal to give consent * prior enrollment in the study

Design outcomes

Primary

MeasureTime frame
Change in weight in 2 years

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026