Effect of de-worming on physical fitness of school-aged children in Yunnan, China
| ISRCTN | ISRCTN25371788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25371788 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/09/2011
- Registration date
- 15/11/2011
- Last edited
- 17/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Department of Epidemiology and Public Health
Swiss Tropical and Public Health Institute
Basel
4002
Switzerland
| Phone | +41 (0)61 284 8129 |
|---|---|
| juerg.utzinger@unibas.ch |
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of de-worming on physical fitness of school-aged children in Yunnan, China: a double-blind, randomised, placebo-controlled trial |
| Study objectives | De-worming can improve the physical fitness and strength of school-aged children |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 17/10/2011 |
| Completion date | 25/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/10/2011 |
| Date of final enrolment | 25/06/2012 |
Locations
Countries of recruitment
- China
- Switzerland
Study participating centre
4002
Switzerland
Sponsor information
Government
Socinstrasse 57
Basel
4002
Switzerland
| Website | http://www.swisstph.ch/ |
|---|---|
"ROR" |
https://ror.org/03adhka07 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
