Condition category
Infections and Infestations
Date applied
09/04/2013
Date assigned
30/04/2013
Last edited
30/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Our team's 2010 survey of poor, rural areas of Guizhou Province found rates of infection with soil transmitted helminths (STHs) to be around 40%. But Chinese government officials are not convinced that STH infection poses any real problem to Chinese schoolchildren. The goal of this study is to see whether an intensive campaign to reduce STH infection has any impact on child health or cognitive performance.

Who can participate?
Our sample will include both school-aged (9-11 years) and preschool-aged (3-5 years) children in the sample villages.

What does the study involve?
The study will have one intervention group and one control group with no intervention. The intervention involves administration of two rounds of albendazole treatment for all village children over age 3 years, health education training for both children and their parents, and an invitation to a health training session led by a local Centers for Disease Control and Prevention (CDC) official.

What are the possible benefits and risks of participating?
All children participating in the study will be dewormed (children in the control group will be dewormed at the conclusion of the endline survey), and families in the intervention group will also have the opportunity to learn about the dangers of STH infection and ways to prevent it. The risks of participating in the study are minimal - albendazole is safe with minimal side effects, mainly limited to mild stomach cramps as the STHs die and are expelled from the host body.

Where is the study run from?
110 villages in poor parts of rural Guizhou Province.

When is the study starting and how long is it expected to run for?
The study will begin in May, 2013, and will continue for 12 months until May, 2014.

Who is funding the study?
The study is funded by grants from the International Initiative for Impact Evaluation (3ie), the UBS Optimus Foundation, and Stanford University.

Who is the main contact?
Alexis Medina
amedina5@stanford.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Rozelle

ORCID ID

Contact details

616 Serra Street
Encina Hall E407
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Deworming and Health Education: A cluster-randomized single-blind controlled trial to address soil-transmitted helminths in rural Guizhou province

Acronym

Study hypothesis

The goal of this study is to see whether an intensive campaign to reduce STH infection has any impact on child health or cognitive performance.

This project involves treatment of children with soil-transmitted helminth infection (Ascaris, hookworm, Trichuris). Depending on the number of worms harbored, infection with parasitic intestinal worms can cause a range of symptoms, including diarrhea, general sickness and weakness, impaired cognitive development, stunted growth, and chronic intestinal blood loss.

Ethics approval

Ethical approval was provided by the Stanford University Human Subjects Research Institutional Review Board on the 15th September 2012 (ref: 25027)

Study design

Interventional cluster-randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Soil-transmitted helminth infection

Intervention

Villagers in the intervention group will participate in the following activities:
1. All village children over age 3 years will be administered two 400 mg tablets of albendazole: one tablet at the start of the project, and another one after 6 months. The local CDC (with help of the village doctor) will be responsible for medication distribution and
administration.
2. All parents of sampled children will receive one-on-one health education training from a trained project team member.
3. All school-aged children in our sample will receive health education training from a trained project team member
4. All parents of children in the village will be invited to a health training session led by a local CDC official with the help of the village doctor.

Villagers in the control group will not participate in any study interventions (no treatment).

Intervention type

Drug

Phase

Not Applicable

Drug names

Albendazole

Primary outcome measures

1. Soil-transmitted helminths (STH) infection rate, measured by a Kato-Katz smear test
2. Child height and weight
3. Student academic performance, measured by performance on a standardized Trends in International Mathematics and Science Study (TIMSS) test
4. Educational readiness for preschool-aged children, measured by performance on a standardized test of educational readiness
5. Cognitive processing, as measured by performance on a test of executive function

Measured at baseline and at end line (12 months after baseline).

Secondary outcome measures

1. Hemoglobin levels, measured by HemoCue 201+ technology
2. Worm burden [eggs per gram (epg)]

Measured at baseline and at endline (12 months after baseline).

Overall trial start date

21/04/2013

Overall trial end date

21/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All school-aged (9-11 years) and preschool-aged (3-5 years) children living in our sample villages in poor parts of rural Guizhou Province will be included in the study.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3300 children

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

21/04/2013

Recruitment end date

21/04/2014

Locations

Countries of recruitment

China

Trial participating centre

616 Serra Street
Stanford
94305
United States of America

Sponsor information

Organisation

Stanford University (USA)

Sponsor details

616 Serra Street
Encina Hall East
5th floor
Stanford
94305
United States of America

Sponsor type

University/education

Website

http://www.stanford.edu/

Funders

Funder type

Charity

Funder name

International Initiative for Impact Evaluation (3ie) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UBS Optimus Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stanford University Global Underdevelopment Action Fund (USA)

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

Publication citations

Additional files

Editorial Notes