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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01029002
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Ability to provide informed consent
* Chronic kidney disease stage 3 and 4
* On ACE inhibitor or ARB for albuminuria if tolerated
* Assessed during eligibility screen:
* Albuminuria \>30 mg/g creatinine
* 25(OH) vitamin D level \>12.5 and \<75 nmol/L
Exclusion Criteria:
* On vitamin D in past 4 weeks
* Plans to relocate out of New York City in the next 6 months
* 25 (OH) Vitamin D level \<12.5 nmol/L
* HIV infection
* History of hypercalcemia or kidney stones
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* SBP \>160 DBP \>100 at screening visit
* Transplanted organ
* Cancer
* Polycystic kidney disease
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01029002
Study Brief:
Protocol Section:
NCT01029002