Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation

NCT03576716 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: STUDY00000608R01DK099199
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; vitamin d catabolism

Outcome Measures

Primary Outcomes (1)

• Change in Metabolic Clearance of D6-25(OH)D3

  Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Change in clearance of D6-25(OH)D3 will be calculated as D6-25(OH)D3 clearance measured during CLEAR-PLUS minus D6-25(OH)D3 clearance previously measured during participation in the related study protocol (without vitamin D3 supplementation). Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration. The change listed is between two timepoints.

  Baseline, 6 months

Secondary Outcomes (3)

• Change in AUC of D6-25(OH)D3

  Baseline, 6 months

• Change in Terminal Half-life of D6-25(OH)D3

  Baseline, 6 months

• Change in Volume of Distribution of D6-25(OH)D3

  Baseline, 6 months

Other Outcomes (5)

• Changes in Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.

  Baseline, 6 months

• Change in the Serum Concentration of Calcium

  Baseline, 7 days

• Change in the Serum Concentration of Creatinine

  Baseline, 7 days

Study Arms (1)

Study Population

EXPERIMENTAL

D6-25-hydroxyvitamin D3 with vitamin D3

Drug: D6-25-hydroxyvitamin D3

Interventions

D6-25-hydroxyvitamin D3 DRUG

Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3

Also known as: stable isotope deuterium-labeled 25(OH)D3

Study Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 33115916 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ian de Boer
• Organization: University of Washington

IDeBoer@Nephrology.washington.edu

206-616-5403

Study Officials

• Ian de Boer, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine/Nephrology

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 3, 2018
• Study Start: June 1, 2018
• Primary Completion: July 8, 2019
• Study Completion: January 1, 2021
• Last Updated: May 17, 2022
• Results First Posted: September 28, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)