Physiological Effects of Vitamin DPhase 1NCT01856348
Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers
A Phase 1 study testing Vitamin D in people with Physiological Effects of Vitamin D, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Effects of Vitamin D
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- age 18 to 65 years at study entry
- signed informed consent form
- Body Mass Index > 18 - < 30 kg/m2
- Participants must not have any other diseases (as assessed by the screening examination)
- Participants must not take any concomitant medications except oral contraceptives in females
- Normal blood count
Who cannot join
- Subjects with confirmed or suspected hypersensitivity towards the study medications
- Contemporaneous participation in any other study
- Females only: pregnancy
- Females only: breast-feeding
- Clinically significant abnormal laboratory findings
- Known or suspected present or past malignancies of any kind
Show all 13Show fewer
- Known or suspected active infections, serious infections in the preceding 3 months
- Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
- Subjects known or suspected not to comply with the study regulations
- Subjects employed at the participating departments of the University Hospital Zürich.
- Known or suspected present or past diseases which may interfere with the study
- smokers
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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
- Conditions
- Physiological Effects of Vitamin D
- Being tested
- Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
| Study group | Role | What they receive |
|---|---|---|
| 1, 25 dihydroxyvitamin D3 intake | Experimental | This is a single arm study. Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D
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.
Measured: 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
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.
Measured: 10 days
Secondary outcomes (2)
Number and characteristics of participants with adverse events
Measured: 10 days
transporter mRNA quantity
Comparison of transporter mRNA levels after ten days of vitamin D3 intake in comparison to the levels before intake.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Effects of Vitamin DStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerd A Kullak-Ublick, Prof MD, Principal investigator, University Hospital Zurich, Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856348
- Sponsor's protocol ID
- PHA-11-VID/FOL-01
- Status last verified
- Aug 2013
- First submitted
- 15 Apr 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01856348
- Acronym / sponsor ID
- PHA-11-VID/FOL-01
- Conditions
- Physiological Effects of Vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 25 dihydroxyvitamin D3 intake | Experimental | Drug: Vitamin DThis is a single arm study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female
- age 18 to 65 years at study entry
- signed informed consent form
- Body Mass Index > 18 - < 30 kg/m2
- Participants must not have any other diseases (as assessed by the screening examination)
Key exclusion criteria (13 listed)
- Subjects with confirmed or suspected hypersensitivity towards the study medications
- Contemporaneous participation in any other study
- Females only: pregnancy
- Females only: breast-feeding
- Clinically significant abnormal laboratory findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D | Drug | 1, 25 dihydroxyvitamin D3 intake |
Primary outcome
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.
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.
2 secondary outcomes
Number and characteristics of participants with adverse events
Time frame: 10 days
transporter mRNA quantity
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd A Kullak-Ublick, Prof MD principal investigator
University Hospital Zurich, Pharmacology and Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Physiological Effects of Vitamin D, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.