Clinical trial NCT02937350: Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Official title: Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
vitamin d catabolism
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Clearance of D6-25(OH)D3
timeFrame: 8 weeks
Secondary outcomes:
measure: AUC of D6-25(OH)D3
timeFrame: 8 weeks
measure: Terminal Half-life of D6-25(OH)D3
timeFrame: 8 weeks
measure: Volume of Distribution of D6-25(OH)D3
timeFrame: 8 weeks
Other outcomes:
measure: Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.
timeFrame: 8 weeks
measure: Change in the Serum Concentration of Calcium
timeFrame: 7 days
measure: Change in the Serum Concentration of Creatinine
timeFrame: Baseline, 7 days
measure: Change in the Serum Concentration of AST
timeFrame: Baseline, 7 days
measure: Change in the Serum Concentration of ALT
timeFrame: Baseline, 7 days
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian de Boer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu S, Zelnick LR, Lin YS, Best CM, Kestenbaum B, Thummel KE, Rose LM, Hoofnagle AN, de Boer IH. Differences in 25-Hydroxyvitamin D Clearance by eGFR and Race: A Pharmacokinetic Study. J Am Soc Nephrol. 2021 Jan;32(1):188-198. doi: 10.1681/ASN.2020050625. Epub 2020 Oct 28.