SarcopeniaNCT05291416
Sarcopenia in Children
An observational study of Sarcopenia and Juvenile Idiopathic Arthritis, run by University Tunis El Manar.
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). Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Juvenile Idiopathic Arthritis
- What is being tested?
- densitometry/ handgrip dynamometer
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: For all patients, we collected the anthropometric data including weight, height, and expressed it as Z scores for age and sex. Body mass index (BMI) was calculated as weight (kg)/height (m2). The disease duration, AJI subtype, disease activity, and treatment were recorded.
Who may be able to join
- children with juvenile idiopathic arthritis fulfilling the ILAR criteria
Who cannot join
- We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.
About this study
Official title: Sarcopenia; a New Issue in Juvenile Idiopathic Arthritis
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
- Conditions
- Sarcopenia, Juvenile Idiopathic Arthritis
- Being tested
- densitometry/ handgrip dynamometer
- Medical subject headings
- Sarcopenia, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
densitometry/ handgrip dynamometerDiagnostic test
all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer
| Study group | Role | What they receive |
|---|---|---|
| 1 | healthy children aged between 4-16 years Receives: Diagnostic Test: densitometry/ handgrip dynamometer | |
| 2 | children aged between 4-16 years, suffering from juvenile idiopathic arthritis Receives: Diagnostic Test: densitometry/ handgrip dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (1)
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lassoued ferjani Hanene, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291416
- Sponsor's protocol ID
- pediatric rheumatology Kassab
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lassoued Ferjani H, Majdoub F, Ben Nessib D, Kaffel D, Triki W, Maatallah K, Hamdi W. Sarcopenia: a new issue in juvenile idiopathic arthritis. A study Protocol. Tunis Med. 2023 Jan 2;101(1):15-18.
PubMed 37682255
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia; a New Issue in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05291416
- Acronym / sponsor ID
- pediatric rheumatology Kassab
- Conditions
- Sarcopenia, Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: densitometry/ handgrip dynamometerhealthy children aged between 4-16 years |
| 2 | – | Diagnostic Test: densitometry/ handgrip dynamometerchildren aged between 4-16 years, suffering from juvenile idiopathic arthritis |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- For all patients, we collected the anthropometric data including weight, height, and expressed it as Z scores for age and sex. Body mass index (BMI) was calculated as weight (kg)/height (m2). The disease duration, AJI subtype, disease activity, and treatment were recorded.
Key inclusion criteria (1 listed)
- children with juvenile idiopathic arthritis fulfilling the ILAR criteria
Key exclusion criteria (1 listed)
- We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| densitometry/ handgrip dynamometerall patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer | Diagnostic test | 1, 2 |
Primary outcome
skeletal muscle mass
Time frame: 4 months
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
1 secondary outcome
muscle strenght
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 37682255Lassoued Ferjani H, Majdoub F, Ben Nessib D, Kaffel D, Triki W, Maatallah K, Hamdi W. Sarcopenia: a new issue in juvenile idiopathic arthritis. A study Protocol. Tunis Med. 2023 Jan 2;101(1):15-18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Juvenile Idiopathic Arthritis, run by University Tunis El Manar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle mass (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.