Condition category
Infections and Infestations
Date applied
14/09/2011
Date assigned
15/11/2011
Last edited
17/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.swisstph.ch/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23690551

Publication citations

  1. 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.

Additional files

Editorial Notes