Official Title: “Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Albendazole 400 mg, given 6 monthly

Primary Measures

• weight gain
• weight for age

Inclusion Criteria:

• children 1-6 years

Exclusion Criteria:

-

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 7 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Makerere University

Overall Clinical Trial Officials and Contacts

Joseph K Konde-Lule, MD DPH MSc Principal Investigator Makerere University  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00344669

Study ID Number: P05267

ClinicalTrials.gov Identifier: NCT00344669

Health Authority: Uganda: National Council for Science and Technology