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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04289727
Eligibility Criteria:
Inclusion Criteria (T1D and Controls):
\- Children within 2 years preceding the onset of the pubertal growth spurt
Inclusion Criteria (T1D participants):
\- documentation of β-cell autoimmunity and need for insulin replacement
Exclusion Criteria:
* Estimated glomerular filtration rate (eGFR)\< 60 ml/mim
* 25(OH)D level \< 20 ng/ml.
* Celiac disease
* Autoimmune thyroid disease
* Addison's disease
* History of pathological fractures
\-- Disorders associated with altered skeletal structure or function
* Bone active drugs in past year
* Diabetes of other or unclear etiology
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT04289727
Study Brief:
Protocol Section:
NCT04289727