Vitamin D SubstitutionPhase 4NCT05733117
Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease
A Phase 4 study testing Vitamin D in people with Vitamin D Substitution, run by Tomas Bata Hospital, Czech Republic at 2 sites in Czechia.
Trial summary
The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitamin D Substitution
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCzechia
- Study dates
- 25 Oct 2022to 1 Jan 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inflammatory bowel disease patients
Who cannot join
- Liver and renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
- Concomitant vitamin D medication
- Pregnancy
Show all 9Show fewer
- Sarcoidosis
- Malignancy
- Inability to obtain valid data from subject
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Not yet recruiting
Faculty Hospital Kralovske Vinohrady
Prague, 10024
Jan Matous, MD, +420267163680, jan.matous1@fnkv.cz
- Recruiting
ThomasBH
Zlín, 76001
Vladimír Kojecký, MD, +420577552510, kojecky@bnzlin.cz
Vladimir Kojecky
About this study
Official title: Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease
The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.
Read the detailed description
Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.
- Conditions
- Vitamin D Substitution
- 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
cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| NanoVitD | Active comparator | Oral nano form of the calciferol Receives: Drug: Vitamin D |
| ConvVitD | Active comparator | Conventional oral calciferol Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D (25OHD) blood level
Change of the D vitamin level after follow-up interval
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start25 Oct 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D SubstitutionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Responsible party
- Principal investigator, Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic
- Investigators
- Vladimír Kojecký, MD, Principal investigator, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733117
- Sponsor's protocol ID
- K092022
- Status last verified
- Feb 2023
- First submitted
- 25 Sep 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05733117
- Acronym / sponsor ID
- K092022
- Conditions
- Vitamin D Substitution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- 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 purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.
Detailed description
Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoVitD | Active comparator | Drug: Vitamin DOral nano form of the calciferol |
| ConvVitD | Active comparator | Drug: Vitamin DConventional oral calciferol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inflammatory bowel disease patients
Key exclusion criteria (9 listed)
- Liver and renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
- Concomitant vitamin D medication
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 Dcholecalciferol | Drug | ConvVitD, NanoVitD |
Primary outcome
Vitamin D (25OHD) blood level
Time frame: 4 months
Change of the D vitamin level after follow-up interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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.
Vladimír Kojecký, MD principal investigator
Tomas Bata Hospital, Czech Republic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Vitamin D Substitution, run by Tomas Bata Hospital, Czech Republic at 2 sites in Czechia.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimír Kojecký (+420577552512, kojecky@bnzlin.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D (25OHD) blood level (time frame: 4 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 17 Feb 2023.