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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00427804
Eligibility Criteria:
Inclusion Criteria:
* Males
* Age 18 to 50
* History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)
Exclusion Criteria:
* Subjects already taking activated vitamin D medications such as calcitriol, Zemplar®, Hectoral®
* Vitamin D deficiency defined as 25(OH)D ≤ 20 ng/ml
* Post-menopausal women (absence of menses for greater than 6 months by history or FSH level \>20)
* History of nephrolithiasis
* History of hypercalcemia or hypercalciuria
* Short bowel disease
* Glucocorticoid use
* Use of osteoporosis medication (bisphosphonate, calcitonin or teriparatide)
* Chronic kidney disease (calculated GFR \<60 ml/min/1.73 m2)
* History of hyperparathyroidism (PTH greater than upper limit of normal) or
* Hypoparathyroidism (PTH below lower limit of normal)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00427804
Study Brief:
Protocol Section:
NCT00427804