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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00677534
Eligibility Criteria:
Inclusion Criteria:
* End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
* Dialysis vintage of at least 6 months duration
* Nutritional vitamin D deficiency, defined as 25(OH)D \<25 ng/ml
* Age 21 to 88 years
Exclusion Criteria:
* Active infection
* Recent hospitalization for acute illness (within last 1 month)
* Refusal to study participation
* Poorly controlled secondary hyperparathyroidism (iPTH\>500)
* History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
* Cinacalcet therapy
* Previous allergy to ergocalciferol
* History of parathyroidectomy
* Current treatment with immunosuppressant medications
* Noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early)
* Functional renal transplant within the last five years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
88 Years
Study:
NCT00677534
Study Brief:
Protocol Section:
NCT00677534