Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT06034795
Eligibility Criteria:
Inclusion Criteria:
* For patients:
* Age \> 6 years
* BMI 3rd - 90th percentile
* Meet the Tel Hashomer criteria (Avi Linhnen 1997)
* Confirmed diagnosis by finding mutation(s) in the MEFV gene
* Taking medication (colchicine) for at least 3 months
* Normal physical activity during the last month, according to the questionnaire that will be distributed
* Free individual history for bone diseases
* Normal thyroid function
* For the control group:
* Age \> 6 years
* BMI 3rd - 90th percentile
* Free individual history for bone diseases
* Normal physical activity according to the questionnaire
* Normal thyroid function
Exclusion Criteria:
* For patients:
* Age \< 6 years
* BMI \< 3rd or \> 90th percentile
* Period of attack period of the disease
* Those who have not started treatment with colchicine
* Those who do not adapt well to taking colchicine
* Decreased physical activity during the last month according to the questionnaire
* Finding from the history of bone diseases that could affect the results
* Taking vitamins that could affect the results
* Existence of a factor that does not allow the performance of Dexa (when for example the safe and appropriate placement of the child cannot be ensured)
* History of previous surgery which forced the patient to be bedridden for a significant period of time. Possible unreliable result of bone mineral density measurement due to reduced physical activity.
* For the control group:
* Age \< 6 years
* BMI \< 3rd or \> 90th percentile
* Taking vitamins that could affect the results
* Decreased physical activity during the last month according to the questionnaire
* History of previous surgery in the last year
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
20 Years
Study:
NCT06034795
Study Brief:
Protocol Section:
NCT06034795