NCT00396500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 1994

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1994

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1996

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
Last Updated

November 7, 2006

Status Verified

November 1, 2006

First QC Date

November 4, 2006

Last Update Submit

November 6, 2006

Conditions

MalnutritionWorm InfestationUnder-Fives

Keywords

DewormingMalnutritionchildrenCommunityIndia

Outcome Measures

Primary Outcomes (1)

  • Change in weight in 2 years

Secondary Outcomes (1)

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

Interventions

Albendazole (400 mg) and/or Vitamin aDRUG

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Refusal to give consent
  • prior enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucknow Commission

Lucknow, Uttar Pradesh, 226003, India

Location

Related Publications (1)

  • 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.

    PMID: 18414647DERIVED

MeSH Terms

Conditions

MalnutritionTrematode Infections

Interventions

AlbendazoleVitamin A

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Shally Awasthi, MD, DNB

    Dept of Pediatrics, King George's Medical University, Lucknow, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2006

First Posted

November 7, 2006

Study Start

April 1, 1994

Study Completion

December 1, 1996

Last Updated

November 7, 2006

Record last verified: 2006-11

Locations

IN(1)