Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

Phase 1

Completed

• Conditions: Physiological Effects of Vitamin D
• Interventions: Drug: Vitamin D

• Registration Number: NCT01856348
• Lead Sponsor: University of Zurich

Brief Summary

The study is conducted to assess the effect of a vitamin D3 supplementation on the activities of two intestinal transporters and on the pharmacokinetics of the transporter substrates folic acid and fexofenadine.

* Trial with medicinal product

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-15
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1, 25 dihydroxyvitamin D3 intake	Vitamin D	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D	10 days	Changes in single-dose pharmacokinetics of racemic fexofenadine at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution.
Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D	10 days	Changes in single-dose pharmacokinetics of folic acid at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution.

Secondary Outcome Measures

Name	Time	Method
Number and characteristics of participants with adverse events	10 days
transporter mRNA quantity	10 days	Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake.

Trial Locations

Locations (1)

University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology; 🇨🇭 Zurich, ZH, Switzerland