NCT00396500

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

Completed Phase 3 Last updated 6 November 2006

What this trial tests

Phase 3 trial testing Albendazole (400 mg) and/or Vitamin a in Malnutrition in 4,000 participants. Completed in 1 December 1996.

Timeline

1 April 1994

1 December 1996

Quick facts

Lead sponsor	King George's Medical University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	4,000
Start date	1 April 1994
Estimated completion	1 December 1996
Sites	1 location across India

Drugs / interventions tested

• Albendazole (400 mg) and/or Vitamin a — full drug profile →

Conditions studied

• Malnutrition — all drugs for Malnutrition →
• Worm Infestation — all drugs for Worm Infestation →
• Under-Fives — all drugs for Under-Fives →

Sponsor

King George's Medical University

Who can join

Adults 1 to 5, any sex, with Malnutrition or Worm Infestation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in weight in 2 years

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial.
   Awasthi S, Peto R, Pande VK, Fletcher RH, et al · · 2008 · cited 33× · PMID 18414647 · DOI 10.1371/journal.pntd.0000223