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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05291416
Other study ID # pediatric rheumatology Kassab
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 31, 2022

Study information

Verified date March 2022
Source University Tunis El Manar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Juvenile idiopathic arthritis (AJI), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. Chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). To our knowledge, no study has focused on the prevalence of sarcopenia in JIA and the data on the muscle disorder are lacking. The purpose of the present study is to detect sarcopenia and identify associated factors in children with JIA


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 16 Years
Eligibility Inclusion Criteria: - children with juvenile idiopathic arthritis fulfilling the ILAR criteria Exclusion Criteria: - We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.

Study Design


Intervention

Diagnostic Test:
densitometry/ handgrip dynamometer
all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Tunis El Manar

Outcome

Type Measure Description Time frame Safety issue
Primary skeletal muscle mass Dual-energy X-ray absorptiometry (DXA) measures the appendicular lean mass ( the sum of the lean mass of the arms and legs) and adjusted to the body mass index 4 months
Secondary muscle strenght Three consecutive trials will be measured by the handgrip dynamometer between the dominant and non-dominant sides. the highest value will be used and adjusted to the body mass index 5 months
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