Effect of Mass Deworming on Child Growth

Low Weight for Age in Preschool Children Clinical Trial

Official title:

Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344669
• Other study ID #: P05267
• Status: Completed
• Phase: N/A
• First received: June 14, 2006
• Last updated: October 16, 2006
• Start date: August 2000
• Est. completion date: November 2003

Study information

• Verified date: June 2006
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age.

Description:

Many children in developing countries get slowed growth because of heavy loads of intestinal helminths. Quite often treatment is not sought because there may not be any obvious symptoms. Slowed growth may manifest as low weight for age or low height for age.

The objective of the study was to estimate the effectiveness of the delivery of an anthelmintic drug through a community child health program on the weight gain of preschool aged children.

Design: This was a cluster randomized controlled trial in 48 parishes in Eastern Uganda. All 48 parishes were participating in a new program for child health; 24 were randomly assigned to offer to children an additional service of anthelmintic treatment. The intervention was 400 mg of albendazole added to the standard services at child days over a 3 years period. All children were offered the drug and the main outcome measure was weight gain.

Results: A total of 27,995 children were recruited into the 2 arms of the study with 14,940 in the treatment arm and 13,055 in the control arm. The intervention arm got an increase in weight gain of about 10% (166 grams per child per year (CI: 16-316) above expected weight gain when treatment was taken twice a year and an increase of 5% when treatment was received approximately annually.

Conclusion: The inclusion of deworming in regularly scheduled health services appears practical and capable of increasing child growth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• children 1-6 years

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Weight for Age in Preschool Children

Intervention

Drug:
• Albendazole 400 mg, given 6 monthly

Locations

Country	Name	City	State
Uganda	48 parishes in Eastern Uganda	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Ministry of Health, Uganda, World Bank

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain
Primary	weight for age