Impact on physical fitness and cognitive ability in school children from southern Côte d'Ivoire after treatment against intestinal helminth infections

ISRCTN ISRCTN37143632
DOI https://doi.org/10.1186/ISRCTN37143632
Secondary identifying numbers N/A
Submission date
25/10/2012
Registration date
19/11/2012
Last edited
14/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Millions of people in the developing world are at risk of parasitic diseases such as malaria and the so-called neglected tropical diseases (NTDs). The latter include, among others, parasitic worm (helminth) infections, such as soil-transmitted helminthiasis and schistosomiasis. There is a lack of studies investigating the effects of infection with multiple parasites (polyparasitism). Due to the long-lasting and un-specific nature of the symptoms, the public health burden can be greatly underestimated. Given that helminth and schistosomiasis infections cause malnutrition and anemia in school-aged children, it is also possible that they reduce their physical fitness, strength and school performance. The main aims of this study is to determine whether polyparasitic infections including soil-transmitted helminths and schistosomiasis have negative consequences on the physical fitness, strength and cognitive abilities of school-aged children in south-central Côte d’Ivoire, and if treatment against these diseases improves performance in infected children.

Who can participate?
All primary school children from grade 3-6 (age range: 8-15 years) will be invited to participate in this study.

What does the study involve?
The children will submit a stool, urine and finger-prick blood sample, and complete physical and cognitive tests and clinical examinations. All study participants will be treated against soil-transmitted helminths and schistosomiasis with a single dose of albendazole and praziquantel at the start of the study and 2 months and 5 months later. Further tests will take place at the end of the study follow-up, 7 months after the start of the study.

What are the possible benefits and risks of participating?
All participating children will benefit from repeated de-worming with albendazole and praziquantel free of charge. Both treatments are shown to be highly effective against the common soil-transmitted helminths and schistosomiasis, respectively, and have good safety profiles. Treatment will also be offered for children with malaria or severely anaemia.

Where is the study run from?
The study will be conducted in a rural primary school in Agboville department, Agnéby region, Côte d’Ivoire.

When is the study starting and how long is it expected to run for?
The study will start in November 2012 and will run for about 7 months.

Who is funding the study?
Swiss National Science Foundation (SNSF).

Who is the main contact?
Prof. Dr Jürg Utzinger
juerg.utzinger@unibas.ch

Contact information

Prof Juerg Utzinger
Scientific

Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4002
Switzerland

Study information

Study designIntervention study with cross-sectional assessment
Primary study designInterventional
Secondary study designCross-section survey
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImpact on physical fitness and cognitive ability in school children from southern Côte d'Ivoire after treatment against soil-transmitted helminths and schistosomiasis
Study objectivesTreatment against soil-transmitted helminths and schistosomiasis can improve the physical fitness, strength and school performance of school-aged children.
Ethics approval(s)1. Ethikkommission beider Basel, Switzerland, 14/04/2011, ref: 30/11 (amendment, 21/06/2011)
2. Comité National d'Ethique et de la Recherche, Côte d'Ivoire, 03/01/2011, ref: 09-2011/MSHP/CNER-P
Health condition(s) or problem(s) studiedNeglected tropical diseases (soil-transmitted helminth and schistosomiasis infections) and malaria
InterventionAll 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Albendazole, praziquantel
Primary outcome measureDifferences (non-infected vs. infected) and changes (before and after treatment) in physical fitness, strength and cognitive ability
Secondary outcome measures1. Reduction of infection prevalence and intensity of soil-transmitted helminths and schistosomiasis
2. Differences and changes in disease-related morbidity measures (malnutrition, anemia, organomegaly)
Overall study start date01/11/2012
Completion date01/06/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit15 Years
SexBoth
Target number of participantsApproximately 300
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2012
Date of final enrolment01/06/2013

Locations

Countries of recruitment

  • Côte d'Ivoire
  • Switzerland

Study participating centre

Swiss Tropical and Public Health Institute
Basel
4002
Switzerland

Sponsor information

Swiss Tropical and Public Health Institute (Switzerland)
Research organisation

Socinstrasse 57
Basel
4002
Switzerland

Website http://www.swisstph.ch/
ROR logo "ROR" https://ror.org/03adhka07

Funders

Funder type

Government

Swiss National Science Foundation [SNSF] (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan