Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Population

D6-25-hydroxyvitamin D3 with vitamin D3

Group Type EXPERIMENTAL

D6-25-hydroxyvitamin D3

Intervention Type DRUG

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

Interventions

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D6-25-hydroxyvitamin D3

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

Intervention Type DRUG

Other Intervention Names

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stable isotope deuterium-labeled 25(OH)D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No