Clinical trial NCT03576716: Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
Official title: Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
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: 2018-07-03
Enrollment: 19
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 determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Metabolic Clearance of D6-25(OH)D3
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in AUC of D6-25(OH)D3
timeFrame: Baseline, 6 months
measure: Change in Terminal Half-life of D6-25(OH)D3
timeFrame: Baseline, 6 months
measure: Change in Volume of Distribution of D6-25(OH)D3
timeFrame: Baseline, 6 months
Other outcomes:
measure: Changes in Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.
timeFrame: Baseline, 6 months
measure: Change in the Serum Concentration of Calcium
timeFrame: Baseline, 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.