Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease (CLEAR)

University of Washington

Status and phase

Completed

Phase 1

Conditions

Chronic Kidney Disease

Treatments

Drug: D6-25-hydroxyvitamin D3

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02937350

STUDY00009578

R01DK099199 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.

Full description

Specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who self-report race as Caucasian, African American or African. The long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Self-reported race Caucasian, African American, or African
Serum total 25(OH)D 10-50 ng/mL
Estimated GFR:
- 60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) <15 mL/min/1.73m2, treated with hemodialysis (N=40)

Exclusion criteria

Primary hyperparathyroidism
Gastric bypass
Tuberculosis or sarcoidosis
Current pregnancy
Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)
Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
Serum calcium > 10.1 mg/dL
Hemoglobin < 10 g/dL