Vitamin D Substitution During Winter Time
Primary Purpose
Vitamin D Substitution
Status
Unknown status
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
Colecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Substitution focused on measuring Vitamin D, Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- Subjects with inflammatory bowel disease
Exclusion Criteria:
- Liver disease
- Renal disease
- Hypercalcemia
- Hyperparathyreoidism
- Chronic pancreatitis
- Concomitant vitamin D medication
- Pregnancy
- Sarcoidosis
- Malignancy
- Inability to obtain valid data from subject
Sites / Locations
- Faculty Hospital Kralovske Vinohrady
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IU/Day
IU/Kg/Day
Arm Description
This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight
This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02958501
First Posted
November 1, 2016
Last Updated
November 4, 2016
Sponsor
Faculty Hospital Kralovske Vinohrady
Collaborators
Nemocnice T.Bati, Zlin, Brno University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02958501
Brief Title
Vitamin D Substitution During Winter Time
Official Title
Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady
Collaborators
Nemocnice T.Bati, Zlin, Brno University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Substitution
Keywords
Vitamin D, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IU/Day
Arm Type
Active Comparator
Arm Description
This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight
Arm Title
IU/Kg/Day
Arm Type
Active Comparator
Arm Description
This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight
Intervention Type
Drug
Intervention Name(s)
Colecalciferol
Intervention Description
Drug
Primary Outcome Measure Information:
Title
Change in vitamin D blood level after follow-up interval
Description
Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Change in vitamin D after follow-up interval according to weight
Description
Change in vitamin D after follow-up interval according to weight. Superiority of weight base dosing to fixed daily dose.
Time Frame
4 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with inflammatory bowel disease
Exclusion Criteria:
Liver disease
Renal disease
Hypercalcemia
Hyperparathyreoidism
Chronic pancreatitis
Concomitant vitamin D medication
Pregnancy
Sarcoidosis
Malignancy
Inability to obtain valid data from subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Matous, MD
Phone
+420267163680
Email
jan.matous1@fnkv.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Kojecky, MD,PhD
Phone
+420577552512
Email
kojecky@bnzlin.cz
Facility Information:
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10024
Country
Czech Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D Substitution During Winter Time
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