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Sponsors and Collaborators: |
Makerere University Ministry of Health, Uganda World Bank |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00344669 |
The purpose of the study was to determine whether periodical mass deworming improves growth in children below six years of age.
Condition | Intervention |
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Low Weight for Age in Preschool Children |
Drug: Albendazole 400 mg, given 6 monthly |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda |
Estimated Enrollment: | 10000 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | November 2003 |
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.
Ages Eligible for Study: | 1 Year to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - children 1-6 years Exclusion Criteria: -
Uganda | |
48 parishes in Eastern Uganda | |
Kampala, Uganda |
Principal Investigator: | Joseph K Konde-Lule, MD DPH MSc | Makerere University |
Study Chair: | John F Mutumba, MBChB, MSc | Ministry of Health, Uganda |
Study ID Numbers: | P05267 |
Study First Received: | June 14, 2006 |
Last Updated: | October 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00344669 History of Changes |
Health Authority: | Uganda: National Council for Science and Technology |
underweight preschool mass deworming |
Albendazole Body Weight Tubulin Modulators |
Anthelmintics Antimitotic Agents Weight Gain |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiplatyhelmintic Agents Mitosis Modulators Anthelmintics |
Antimitotic Agents Pharmacologic Actions Anticestodal Agents Albendazole Antiparasitic Agents Therapeutic Uses Tubulin Modulators |