Vitamin D DeficiencyPhase 4ViDImmunNCT01845142
Immunologic Action of a Single Dose Cholecalciferol
A Phase 4 study testing single administration of 100.000 I.U. vitamin D in people with Vitamin D Deficiency, run by Margitta Worm at 1 site in Germany.
Trial summary
Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- single administration of 100.000 I.U. vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Apr 2014
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent
- 18-60 yrs
- 25-hydroxyvitamin D serum below 50 nmol/L
- women only: effective contraception
Who cannot join
- 25-hydroxyvitamin D serum above 50 nmol/L
- body-mass index <18 or >30 kg per m2
- planned UV-exposure (UV-index > 5)
- hypersensitivity to vitamin D
- history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
- treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides
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- immobile patients
- out of normal range on screening visit (calcium,phosphate,creatinin,hematology)
- psychiatric hospitalization
- pregnancy / breast-feeding
- dependency / relationship on sponsor
- concomitant participation in other clinical trials (30 days before)
- drug or alcohol abuse
- lack of compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dpt of Dermatology and Allergology, Charité University Medicine Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.
Read the detailed description
Vitamin D-deficient individuals will receive once
- double-blind, placebo controlled 100.000 I.U.vitamin D3
- intramuscular or subcutaneous
Blood will be taken over time and
- immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
- vitamin D-metabolites will be monitored
- Conditions
- Vitamin D Deficiency
- Being tested
- single administration of 100.000 I.U. vitamin D, Placebo
- Keywords
- vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single administration of 100.000 I.U. vitamin DDrug
Also called cholecalciferol
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| intramuscular 100.000 I.U. vitamin D3 | Active comparator | intramuscular 100.000 I.U. vitamin D3 Receives: Drug: single administration of 100.000 I.U. vitamin D |
| intramuscular placebo | Placebo comparator | intramuscular 0.9% sodium chloride Receives: Drug: Placebo |
| subcutaneous 100.000 I.U. vitamin D3 | Active comparator | subcutaneous 100.000 I.U. vitamin D3 Receives: Drug: single administration of 100.000 I.U. vitamin D |
| subcutaneous placebo | Placebo comparator | subcutaneous 0.9% sodium chloride Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
Peripheral B cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry. Vitamin D-responsive B cells will be quantified before and 1 week, 1 month and 3 months after vitamin D administration.
Measured: up to 3 months
Secondary outcomes (4)
Characterize vitamin D-responding myeloid immune cells
peripheral blood mononuclear cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and monocytes will be characterized phenotypically by flow-cytometry.
Measured: up to 3 months
Impact of vitamin D on specific humoral memory
The humoral immunoglobulin response against selected endogenous viruses (anti-virus-specific-Ig) over time will be determined before and 3 months after vitamin D administration.
Measured: up to 3 months
Vitamin D pharmacokinetics
Vitamin D-metabolites including 25-hydroxyvitamin D will be determined up to 3 months after administration of a single dose-vitamin D.
Measured: up to 3 months
Characterize vitamin D-responsive T cells
peripheral T cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry according to functional subpopulations.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margitta Worm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Margitta Worm, Prof, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845142
- Sponsor's protocol ID
- ViDImmun
- Other IDs
- 2012-003217-33
- Acronym
- ViDImmun
- Status last verified
- Jun 2015
- First submitted
- 24 Apr 2013
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
- ClinicalTrials.gov ID
- NCT01845142
- Acronym / sponsor ID
- ViDImmun / ViDImmun
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Margitta WormUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 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.
Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.
Detailed description
Vitamin D-deficient individuals will receive once
- double-blind, placebo controlled 100.000 I.U.vitamin D3
- intramuscular or subcutaneous
Blood will be taken over time and
- immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
- vitamin D-metabolites will be monitored
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| intramuscular 100.000 I.U. vitamin D3 | Active comparator | Drug: single administration of 100.000 I.U. vitamin Dintramuscular 100.000 I.U. vitamin D3 |
| intramuscular placebo | Placebo comparator | Drug: Placebointramuscular 0.9% sodium chloride |
| subcutaneous 100.000 I.U. vitamin D3 | Active comparator | Drug: single administration of 100.000 I.U. vitamin Dsubcutaneous 100.000 I.U. vitamin D3 |
| subcutaneous placebo | Placebo comparator | Drug: Placebosubcutaneous 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- informed consent
- 18-60 yrs
- 25-hydroxyvitamin D serum below 50 nmol/L
- women only: effective contraception
Key exclusion criteria (14 listed)
- 25-hydroxyvitamin D serum above 50 nmol/L
- body-mass index <18 or >30 kg per m2
- planned UV-exposure (UV-index > 5)
- hypersensitivity to vitamin D
- history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
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 |
|---|---|---|
| single administration of 100.000 I.U. vitamin DAlso: cholecalciferol | Drug | intramuscular 100.000 I.U. vitamin D3, subcutaneous 100.000 I.U. vitamin D3 |
| Placebo | Drug | intramuscular placebo, subcutaneous placebo |
Primary outcome
Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
Time frame: up to 3 months
Peripheral B cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry. Vitamin D-responsive B cells will be quantified before and 1 week, 1 month and 3 months after vitamin D administration.
4 secondary outcomes
Characterize vitamin D-responding myeloid immune cells
Time frame: up to 3 months
Impact of vitamin D on specific humoral memory
Time frame: up to 3 months
Vitamin D pharmacokinetics
Time frame: up to 3 months
Characterize vitamin D-responsive T cells
Time frame: up to 3 months
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 25 Jun 2015.
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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.
Margitta Worm, Prof principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing single administration of 100.000 I.U. vitamin D in people with Vitamin D Deficiency, run by Margitta Worm at 1 site in Germany.
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 4 inclusion and 14 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 25 Jun 2015. 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 Germany. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in the numbers of vitamin D-responsive B cells after vitamin D administration. (time frame: up to 3 months). 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 25 Jun 2015.