Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

August 9, 2013 updated by: University of Zurich

Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. male or female
  2. age 18 to 65 years at study entry
  3. signed informed consent form
  4. Body Mass Index > 18 - < 30 kg/m2
  5. Participants must not have any other diseases (as assessed by the screening examination)
  6. Participants must not take any concomitant medications except oral contraceptives in females
  7. Normal blood count

Exclusion criteria:

  1. Subjects with confirmed or suspected hypersensitivity towards the study medications
  2. Contemporaneous participation in any other study
  3. Females only: pregnancy
  4. Females only: breast-feeding
  5. Clinically significant abnormal laboratory findings
  6. Known or suspected present or past malignancies of any kind
  7. Known or suspected active infections, serious infections in the preceding 3 months
  8. Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
  9. Subjects known or suspected not to comply with the study regulations
  10. Subjects employed at the participating departments of the University Hospital Zürich.
  11. Known or suspected present or past diseases which may interfere with the study
  12. smokers
  13. alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1, 25 dihydroxyvitamin D3 intake
This is a single arm study.
Drug: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D
Time Frame: 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.
10 days
Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D
Time Frame: 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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and characteristics of participants with adverse events
Time Frame: 10 days
10 days
transporter mRNA quantity
Time Frame: 10 days
Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Gerd A Kullak-Ublick, Prof MD, University Hospital Zurich, Pharmacology and Toxicology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHA-11-VID/FOL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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