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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN37143632 |
Date of registration:
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19/11/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Impact on physical fitness and cognitive ability in school children from southern Côte d'Ivoire after treatment against intestinal helminth infections
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Scientific title:
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Impact on physical fitness and cognitive ability in school children from southern Côte d'Ivoire after treatment against soil-transmitted helminths and schistosomiasis |
Date of first enrolment:
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01/11/2012 |
Target sample size:
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300 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN37143632 |
Study type:
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Interventional |
Study design:
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Intervention study with cross-sectional assessment (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Cote d'Ivoire
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Juerg
Utzinger |
Address:
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Swiss Tropical and Public Health Institute
Socinstrasse 57
4002
Basel
Switzerland |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Primary school child, aged 8-15 years, male or female 2. Written informed consent by a parent/guardian on behalf of the child 3. Submission of 1 urine, 1 stool and 1 finger-prick blood sample at baseline 4. Completion of clinical, 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. Completion of cognitive testing 8. Absence of difficult health condition (clinical malaria, severe anemia, respiratory disease or other major illnesses) as assessed by a medical doctor at baseline 9. No known or reported drug allergy to albendazole or praziquantel 10. Treatment with albendazole and praziquantel
Exclusion criteria: 1. Children below the age of 8 years or above 15 years 2. No written informed consent 3. No complete set of urine, stool and blood sample 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 or praziquantel 6. Absence/refusal of albendazole and/or praziquantel treatment 7. Attending other clinical trials during the study period
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neglected tropical diseases (soil-transmitted helminth and schistosomiasis infections) and malaria Infections and Infestations Schistosomiasis, unspecified
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Intervention(s)
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All participants of the study will be treated against soil-transmitted helminths and schistosomiasis with a single dose of albendazole (400 mg) and praziquantel (40 mg/kg), respectively, at baseline, 2 month, 5 months and 7 months (follow-up assessment) after launch of the study.
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Primary Outcome(s)
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Differences (non-infected vs. infected) and changes (before and after treatment) in physical fitness, strength and cognitive ability
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Secondary Outcome(s)
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1. Reduction of infection prevalence and intensity of soil-transmitted helminths and schistosomiasis 2. Differences and changes in disease-related morbidity measures (malnutrition, anemia, organomegaly)
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Source(s) of Monetary Support
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Swiss National Science Foundation [SNSF] (Switzerland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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