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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04227834
Other study ID # STH032019
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 4, 2019
Est. completion date March 2, 2020

Study information

Verified date January 2020
Source Universitas Sumatera Utara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Soil-transmitted helminth (STH) infections caused by Ascaris lumbricoides, Trichuris trichiura, or hookworm, affect approximately 1.5 millions individuals primarily in tropical and subtropical regions. STHs infections have been associated with delay in growth and development in children. The prevalence in Indonesia varied from 45% to 65%, but in poor sanitation areas the prevalence can increased to 80%. World Health Organization currently recommends mass treatment with benzimidazoles and health hygiene education to control the disease. In this study we evaluated the effectiveness of single and four-monthly health hygiene education to STH reinfection rates among school-aged children in Mandailing Natal district, North Sumatera province, Indonesia.


Description:

In this study we evaluate the prevalence of STH among school-aged children using Kato Katz examination prior to enrolment to the study. Two elementary schools in Mandailing Natal district, North Sumatera province, Indonesia have been selected and received either a single or repeated health hygiene education. Preliminary knowledge was also assessed using a questionnaire. Infected children received treatment of albendazole 400 mg for 3 days. Evaluation on reinfection status and STH knowledge is done at 4 month, 8 month and 12 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 432
Est. completion date March 2, 2020
Est. primary completion date March 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole

Exclusion Criteria:

- Parents who refused to participate in the study

- Severe malnutrition

- Co-infected with other helminth infections

Study Design


Intervention

Behavioral:
Health hygiene education
A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children

Locations

Country Name City State
Indonesia Singkuang sub-district, Mandailing Natal district Panyabungan North Sumatera

Sponsors (1)

Lead Sponsor Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children STH prevalence at 12 months 12 months
Secondary Prevalence of STHs among school-aged children prior to intervention Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0 STH prevalence at month 0
Secondary Knowledge of STHs prevention measures among school-aged children before and after intervention A questionnaire used to evaluate the knowledge about STHs prevention 12 months
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