Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

ClinicalTrials.gov ID

NCT05733117

Lead Sponsor

Tomas Bata Hospital, Czech RepublicOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

120Estimated

Last Update Posted

Feb 17, 2023Actual

Start Date

Oct 25, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Jan 1, 2024Estimated

Official Title

Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease

Brief Summary

The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

Detailed Description

Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.

• Vitamin D Substitution

• Vitamin D

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• The inflammatory bowel disease patients

Exclusion Criteria:

• Liver and renal disease
• Hypercalcemia
• Hyperparathyreoidism
• Chronic pancreatitis
• Concomitant vitamin D medication
• Pregnancy
• Sarcoidosis
• Malignancy
• Inability to obtain valid data from subject

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Tomas Bata Hospital, Czech RepublicOTHER

Collaborators

Faculty Hospital Kralovske VinohradyOTHER_GOV

kojecky@bnzlin.cz+420577552510

• Vitamin D Supplementation in Crohn's Patients

  NCT00742781

  CompletedInterventionalPhase 1Updated Jul 26, 2013
• Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

  NCT01877577

  CompletedInterventionalNot ApplicableUpdated Jul 2, 2014
• the Effect of Vitamin D in Crohn's Disease

  NCT04134065

  Unknown statusInterventionalEarly Phase 1Updated Oct 21, 2019
• Vitamin D Substitution During Winter Time

  NCT02958501

  Unknown statusInterventionalPhase 4Updated Nov 8, 2016
• Influence of Vitamin D on Inflammatory Bowel Disease Remission

  NCT01121796

  Unknown statusInterventionalNot ApplicableUpdated May 12, 2010
• Vitamin D Supplementation in Adult Crohn's Disease

  NCT01369667

  CompletedInterventionalPhase 4Updated Aug 18, 2015