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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576716
Recruitment Status : Active, not recruiting
First Posted : July 3, 2018
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian deBoer, University of Washington

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. 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: D6-25-hydroxyvitamin D3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Population
D6-25-hydroxyvitamin D3 with vitamin D3
Drug: D6-25-hydroxyvitamin D3
Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Other Name: stable isotope deuterium-labeled 25(OH)D3




Primary Outcome Measures :
  1. Change in metabolic clearance of D6-25(OH)D3 [ Time Frame: Approximately 6 months ]
    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).


Secondary Outcome Measures :
  1. Change in AUC of D6-25(OH)D3 [ Time Frame: Approximately 6 months ]
    AUC is calculated using the linear trapezoidal method. Change in the AUC of D6-25(OH)D3 will be calculated as D6-25(OH)D3 AUC measured during CLEAR-PLUS minus D6-25(OH)D3 AUC previously measured during participation in the related study protocol (without vitamin D3 supplementation).

  2. Change in terminal half-life of D6-25(OH)D3 [ Time Frame: Approximately 6 months ]
    Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Change in the terminal half-life of D6-25(OH)D3 will be calculated as D6-25(OH)D3 half-life measured during CLEAR-PLUS minus D6-25(OH)D3 half-life previously measured during participation in the related study protocol (without vitamin D3 supplementation).

  3. Change in volume of distribution of D6-25(OH)D3 [ Time Frame: Approximately 6 months ]
    Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Change in the volume of distribution of D6-25(OH)D3 will be calculated as D6-25(OH)D3 volume of distribution measured during CLEAR-PLUS minus D6-25(OH)D3 volume of distribution previously measured during participation in the related study protocol (without vitamin D3 supplementation).


Other Outcome Measures:
  1. Changes in metabolic formation clearance of D6-25(OH)D3 metabolites. [ Time Frame: Approximately 6 months ]
    Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Changes in the metabolic formation clearance of D6-25(OH)D3 metabolites will be calculated as metabolic formation clearance measured during CLEAR-PLUS minus metabolic formation clearance previously measured during participation in the related study protocol (without vitamin D3 supplementation).

  2. Change in the serum concentration of calcium [ Time Frame: 7 days ]
    Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration

  3. Change in the serum concentration of creatinine [ Time Frame: 7 days ]
    Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration

  4. Change in the serum concentration of AST [ Time Frame: 7 days ]
    Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration

  5. Change in the serum concentration of ALT [ Time Frame: 7 days ]
    Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576716


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ian de Boer, MD, MS University of Washington
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Responsible Party: Ian deBoer, Professor, Medicine/Nephrology, University of Washington
ClinicalTrials.gov Identifier: NCT03576716    
Other Study ID Numbers: STUDY00000608
R01DK099199 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded individual participant data may be shared with other researchers under mutually agreeable terms.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian deBoer, University of Washington:
chronic kidney disease
vitamin d catabolism
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents