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Note: This record shows only the 20 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: ISRCTN
Last refreshed on: 5 August 2014
Main ID:  ISRCTN37143632
Date of registration: 19/11/2012
Primary sponsor: Swiss Tropical and Public Health Institute (Switzerland)
Public title: Impact on physical fitness and cognitive ability in school children from southern Côte d?Ivoire after treatment against intestinal helminth infections N/A
Scientific title: 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: Nov 1 2012
Target sample size: Approximately 300
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN37143632
Study type:  Interventional
Study design:  Intervention study with cross-sectional assessment  
Countries of recruitment
Cote d'Ivoire
Contacts
Name: Juerg  Utzinger
Address:  Swiss Tropical and Public Health Institute Socinstrasse 57 4002 Basel Switzerland
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Neglected tropical diseases (soil-transmitted helminth and schistosomiasis infections) and malaria
Intervention(s)
All participants of the study will be treated against soil-transmitted helminths and schistosomiasis with a single dose of albendazole (400mg) and praziquantel (40mg/kg), respectively, at baseline, 2 month, 5 months and 7 months (follow-up assessment) after launch of the study.
Primary Outcome(s)
Differences (non-infected vs. infected) and changes (before and after treatment) in physical fitness, strength and cognitive ability
Secondary Outcome(s)
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)
Secondary ID(s)
N/A
Source(s) of Monetary Support
Swiss National Science Foundation [SNSF] (Switzerland)
Secondary Sponsor(s)
N/A
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