Plain English Summary
Background and study aims:
The most common parasitic worms that affect humans are the roundworm, whipworm and hookworm. Humans can be infected by eating food contaminated with the eggs of these parasitic worms or if the worms penetrate the skin. Parasitic worm infections can cause reduced growth rate (stunting) and wasting in school-aged children, and it is also possible that these parasitic worms reduce their physical fitness and strength.
The aim of this study is to determine whether de-worming has an effect on the physical fitness and strength of school-aged children in south-western Yunnan, China.
Who can participate?
Primary school children, aged 9-12 years, who are infected with one or more species of parasitic worms, but do not have major systemic illnesses.
What does the study involve?
The participants were subjected to tests to see if they are infected by parasitic worms, and were required to provide stool samples for analysis. Measurements of the participants weight, height and skinfolds were taken, as well as assessments on their performance in a 20m shuttle run, grip strength and standing broad jump tests. The participants randomly allocated to two groups to receive either albendazole or placebo (a dummy drug). The examinations were carried out before, during and after the participants were given treatment with albendazole or placebo.
What are the possible benefits and risks of participating?
Those in the albendazole group will no longer be infected with parasitic worms. Those who were not, would still benefit as all participants were given a single dose of albendazole free of charge at the end of the study. There were no known risks associated with taking part in this study.
Where is the study run from?
Rural primary schools in Menghai County, Xishuangbanna Dai, Yunnan province, China.
When is the study starting and how long is it expected to run for?
The study started in October 2011 and ran for approximately 8 months.
Who is funding the study?
Swiss Tropical and Public Health Institute, Switzerland.
Who is the main contact?
Prof Jürg Utzinger
juerg.utzinger@unibas.ch
Trial website
Contact information
Type
Scientific
Primary contact
Prof Juerg Utzinger
ORCID ID
Contact details
Department of Epidemiology and Public Health
Swiss Tropical and Public Health Institute
Basel
4002
Switzerland
+41 (0)61 284 8129
juerg.utzinger@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of de-worming on physical fitness of school-aged children in Yunnan, China: a double-blind, randomised, placebo-controlled trial
Acronym
Study hypothesis
De-worming can improve the physical fitness and strength of school-aged children
Ethics approval
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
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Soil-transmitted helminth infections
Intervention
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)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Changes in physical fitness and strength
Secondary outcome measures
1. Reduction of infection prevalence and intensity of soil-transmitted helminths and subsequent re-infection pattern
2. Changes in anthropometric and haemoglobin measurements
Overall trial start date
17/10/2011
Overall trial end date
25/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
250
Participant exclusion criteria
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
Recruitment start date
17/10/2011
Recruitment end date
25/06/2012
Locations
Countries of recruitment
China
Trial participating centre
Department of Epidemiology and Public Health
Basel
4002
Switzerland
Sponsor information
Organisation
Swiss Tropical and Public Health Institute (Switzerland)
Sponsor details
Socinstrasse 57
Basel
4002
Switzerland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swiss Tropical and Public Health Institute (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23690551
Publication citations
-
Results
Yap P, Du ZW, Wu FW, Jiang JY, Chen R, Zhou XN, Hattendorf J, Utzinger J, Steinmann P, Rapid re-infection with soil-transmitted helminths after triple-dose albendazole treatment of school-aged children in Yunnan, People's Republic of China., Am. J. Trop. Med. Hyg., 2013, 89, 1, 23-31, doi: 10.4269/ajtmh.13-0009.