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Pharmacokinetics of Calcifediol and Cholecalciferol

NCT02333682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-08-06

No results posted yet for this study

Summary

The investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.

Conditions

Interventions

DIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D) 10 mcg

25(OH)D3 (Calcifediol Hy.D)

DIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D) 15 mcg

25(OH)D3 (Calcifediol Hy.D)

DIETARY_SUPPLEMENT

25(OH)D3 (Calcifediol Hy.D) 20 mcg

25(OH)D3 (Calcifediol Hy.D)

DIETARY_SUPPLEMENT

Vitamin D3 (Cholecalciferol) 20 mcg

Vitamin D3 (Cholecalciferol)

Sponsors & Collaborators

  • Leatherhead Food Research

    collaborator INDUSTRY

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Hull, MSc · Leatherhead Food Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333682 on ClinicalTrials.gov