Clinical trial NCT00396500: Deworming and Vitamin A (DEVTA) Prepilot Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malnutrition
Worm Infestation
Under-Fives
Keywords: Deworming
Malnutrition
children
Community
India
Lead sponsor: King George's Medical University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2006-11-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal to give consent
* prior enrollment in the study

Primary outcomes:
measure: Change in weight in 2 years
Secondary outcomes:
measure: Secondary: Weight and Height gain in underweight, stunted and wasted children
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Lucknow Commission
state: Uttar Pradesh
Study officials:
affiliation: Dept of Pediatrics, King George's Medical University, Lucknow, India
name: Shally Awasthi, MD, DNB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e223. doi: 10.1371/journal.pntd.0000223.