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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
Faculty Hospital Kralovske Vinohrady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Substitution focused on measuring Vitamin D, Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 1, 2016
Last Updated
November 4, 2016
Sponsor
Faculty Hospital Kralovske Vinohrady
Collaborators
Nemocnice T.Bati, Zlin, Brno University Hospital
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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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