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ISRCTN
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ISRCTN25371788
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ClinicalTrials.gov identifier
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Public title
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Effect of de-worming on physical fitness of school-aged children in Yunnan, China
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Scientific title
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Effect of de-worming on physical fitness of school-aged children in Yunnan, China: a double-blind, randomised, placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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De-worming can improve the physical fitness and strength of school-aged children
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Lay summary
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Lay summary under review
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Ethics approval
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1. Ethics Committee of Basel (Ethikkommission beider Basel) (EKBB, Switzerland; reference no. 144/11) approved on 9 May 2011 (original proposal) and 16 August 2011 (amendment)
2. Academic Board of the National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (IPD/China CDC) approved on 25 April 2011
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Study design
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Double-blind randomised placebo-controlled trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Soil-transmitted helminth infections
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Participants - inclusion criteria
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1. Primary school child, aged 9-12 years, male or female
2. Written informed consent by a parent / guardian on behalf of the child
3. Submission of two stool samples at baseline
4. Completion of anthropometric and haemoglobin measurements at baseline
5. Completion of 20 m shuttle run test at baseline
6. Completion of grip strength test and standing broad jump test at baseline
7. Infected with one or more common soil-transmitted helminths (Ascaris lumbricoides, Trichuris trichuria, hookworm)
8. Absence of major systemic illnesses, as assessed by a medical doctor at baseline
9. No known or reported drug allergy to albendazole
10. Treatment with albendazole (or matching placebo)
11. Anticipated residence in the study area for at least 1 year
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Participants - exclusion criteria
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1. Children below the age of 9 years or above 12 years
2. No written informed consent
3. Less than 2 stool samples submitted at baseline
4. Presence of medical condition that prevents child from completing the physical fitness and strength tests
5. Known or reported drug allergy to albendazole
6. Absence/refusal of albendazole treatment (or matching placebo)
7. Attending other clinical trials during the study period
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Anticipated start date
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17/10/2011
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Anticipated end date
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25/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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250
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Interventions
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Participants who were diagnosed with soil-transmitted helminths at the baseline parasitological examination will be randomly allocated to the following treatment arms:
Treatment arm 1: triple-dose albendazole (400 mg daily for 3 consecutive days)
Treatment arm 2: triple-dose placebo (single dose daily for 3 consecutive days)
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Primary outcome measure(s)
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Changes in physical fitness and strength
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Secondary outcome measure(s)
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1. Reduction of infection prevalence and intensity of soil-transmitted helminths and subsequent re-infection pattern
2. Changes in anthropometric and haemoglobin measurements
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Sources of funding
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Swiss Tropical and Public Health Institute (Switzerland)
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Trial website
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Publications
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Contact name
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Prof
Juerg
Utzinger
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Address
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Department of Epidemiology and Public Health
Swiss Tropical and Public Health Institute
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Tel
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+41 (0)61 284 8129
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Fax
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+41 (0)61 284 8105
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Email
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juerg.utzinger@unibas.ch
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Sponsor
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Swiss Tropical and Public Health Institute (Switzerland)
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Address
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Socinstrasse 57
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City/town
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Basel
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Zip/Postcode
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4002
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Country
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Switzerland
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Sponsor website:
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http://www.swisstph.ch/
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Date applied
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14/09/2011
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Last edited
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15/11/2011
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Date ISRCTN assigned
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15/11/2011
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