Vitamin D Substitution During Winter Time

Vitamin D Substitution Clinical Trial

Official title:

Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02958501
• Other study ID #: DV1607
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 1, 2016
• Last updated: November 4, 2016
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Jan Matous, MD
• Phone: +420267163680
• Email: jan.matous1[@]fnkv.cz
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Vitamin D Substitution

Intervention

Drug:
• Colecalciferol
Drug

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital Kralovske Vinohrady	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady	Brno University Hospital, Nemocnice T.Bati, Zlin

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 Months	No
Secondary	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.	4 Months	No