- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344669
Effect of Mass Deworming on Child Growth
Increased Weight Gain in Preschool Children Due to Mass Albendazole Treatment Given During "Child Health Days" in Uganda
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda
- 48 parishes in Eastern Uganda
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children 1-6 years
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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weight gain
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weight for age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph K Konde-Lule, MD DPH MSc, Makerere University
- Study Chair: John F Mutumba, MBChB, MSc, Ministry of Health, Uganda
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Albendazole 400 mg, given 6 monthly
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Swiss Tropical & Public Health InstitutePublic Health Laboratory Ivo de CarneriCompletedTrichuris Trichiura; InfectionTanzania
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GlaxoSmithKlineCompleted
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Jennifer KeiserPublic Health Laboratory Ivo de CarneriCompletedHookworm Infections | Helminthes; Infestation, Intestinal | Ascariasis | TrichuriasisTanzania
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Bial - Portela C S.A.Completed
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Noguchi Memorial Institute for Medical ResearchGhana Health ServicesCompleted
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Jennifer KeiserPublic Health Laboratory Ivo de CarneriNot yet recruitingHookworm Infections | Ascariasis | TrichuriasisTanzania
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Jennifer KeiserPublic Health Laboratory Ivo de CarneriNot yet recruitingHookworm Infections | Ascariasis | TrichuriasisTanzania
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Jennifer KeiserCentre Suisse de Recherches Scientifiques en Cote d'IvoireCompletedHookworm Infections | Ascariasis | TrichuriasisCôte D'Ivoire
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Leonardo ClavijoAmgenUnknownPeripheral Arterial DiseaseUnited States
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King George's Medical UniversityUnited States Agency for International Development (USAID)Completed