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Vitamin D Substitution During Winter Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958501
Recruitment Status : Unknown
Verified November 2016 by MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady.
Recruitment status was:  Not yet recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborators:
Nemocnice T.Bati, Zlin
Brno University Hospital
Information provided by (Responsible Party):
MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady

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)

Condition or disease Intervention/treatment Phase
Vitamin D Substitution Drug: Colecalciferol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
Study Start Date : November 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: IU/Day
This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight
Drug: Colecalciferol
Drug

Active Comparator: IU/Kg/Day
This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight
Drug: Colecalciferol
Drug




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in vitamin D after follow-up interval according to weight [ Time Frame: 4 Months ]
    Change in vitamin D after follow-up interval according to weight. Superiority of weight base dosing to fixed daily dose.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958501


Contacts
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Contact: Jan Matous, MD +420267163680 jan.matous1@fnkv.cz
Contact: Vladimir Kojecky, MD,PhD +420577552512 kojecky@bnzlin.cz

Locations
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Czech Republic
Faculty Hospital Kralovske Vinohrady
Prague, Czech Republic, 10024
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
Nemocnice T.Bati, Zlin
Brno University Hospital
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Responsible Party: MUDr. Jan Matous, Jan Matous, MD, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT02958501    
Other Study ID Numbers: DV1607
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady:
Vitamin D
Inflammatory Bowel Diseases
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents