Vitamin D SubstitutionPhase 4NCT02958501
Vitamin D Substitution During Winter Time
A Phase 4 study testing Colecalciferol in people with Vitamin D Substitution, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vitamin D Substitution
- What is being tested?
- Colecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2016to May 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with inflammatory bowel disease
Who cannot join
- Liver disease
- Renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
- Concomitant vitamin D medication
Show all 10Show fewer
- Pregnancy
- Sarcoidosis
- Malignancy
- Inability to obtain valid data from subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)
Read the detailed description
Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.
- Conditions
- Vitamin D Substitution
- Being tested
- Colecalciferol
- Keywords
- Vitamin D, Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColecalciferolDrug
Drug
| Study group | Role | What they receive |
|---|---|---|
| IU/Day | Active comparator | This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight Receives: Drug: Colecalciferol |
| IU/Kg/Day | Active comparator | This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight Receives: Drug: Colecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D blood level after follow-up interval
Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.
Measured: 4 Months
Secondary outcomes (1)
Change in vitamin D after follow-up interval according to weight
Change in vitamin D after follow-up interval according to weight. Superiority of weight base dosing to fixed daily dose.
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 posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Collaborators
- Nemocnice T.Bati, Zlin, Brno University Hospital
- Responsible party
- Principal investigator, MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958501
- Sponsor's protocol ID
- DV1607
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
- ClinicalTrials.gov ID
- NCT02958501
- Acronym / sponsor ID
- DV1607
- Conditions
- Vitamin D Substitution
- Keywords
- Vitamin D, Inflammatory Bowel Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Collaborators
- Nemocnice T.Bati, Zlin, Brno University Hospital
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 8 Nov 2016 (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 purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)
Detailed description
Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IU/Day | Active comparator | Drug: ColecalciferolThis is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight |
| IU/Kg/Day | Active comparator | Drug: ColecalciferolThis is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with inflammatory bowel disease
Key exclusion criteria (10 listed)
- Liver disease
- Renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
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 |
|---|---|---|
| ColecalciferolDrug | Drug | IU/Day, IU/Kg/Day |
Primary outcome
Change in vitamin D blood level after follow-up interval
Time frame: 4 Months
Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.
1 secondary outcome
Change in vitamin D after follow-up interval according to weight
Time frame: 4 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- 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.
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 Colecalciferol in people with Vitamin D Substitution, run by Faculty Hospital Kralovske Vinohrady at 1 site 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 10 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 8 Nov 2016. 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 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 Jan Matous, MD (+420267163680, jan.matous1@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vitamin D blood level after follow-up interval (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 8 Nov 2016.