Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation (CLEAR-PLUS)

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

NCT03576716

STUDY00000608

R01DK099199 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.

Full description

We expect that this study will enhance interpretation of available diagnostic tests, inform the results of ongoing large clinical trials of vitamin D supplements, and help develop new strategies to target vitamin D to improve health.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF (NCT03104855)
Age ≥ 18 years
Self-reported race Caucasian, African American, or African

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)
History of kidney transplantation (unless failed transplant now treated with hemodialysis)
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