N/A N=56 Randomized Treatment

Impact of Vitamin D Therapies on Chronic Kidney Disease

Chronic Kidney Disease (CKD) · End-stage Renal Disease (ESRD)

Bottom Line

View on ClinicalTrials.gov: NCT01222234 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Monocyte Protein Expression — 34110; 38540; 1359; 1360 relative fluorescence units

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cholecalciferol - CKD (Drug); Calcitriol - CKD (Device); Cholecalciferol - non-CKD (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Kansas Medical Center
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Monocyte Protein Expression	34110; 38540; 1359; 1360; 2799; 3468	—
PRIMARY Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol	1.59; 3.59	—

Summary

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Eligibility Criteria

Inclusion Criteria

Chronic kidney disease w/GFR 75pg/mL

Exclusion Criteria

Active infection
Recent hospitalization for acute illness (within last month)
Refusal to study participation
History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
Allergy to cholecalciferol or calcitriol
History of parathyroidectomy
Functional renal transplant within 5 years
Current treatment with immunosuppressant medications
Noncompliance with prescribed medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01222234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.