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Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Primary Purpose

Vitamin D Substitution

Status

Recruiting

Phase

Phase 4

Locations

Czechia

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional prevention trial for Vitamin D Substitution

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty Hospital Kralovske Vinohrady
ThomasBHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

NanoVitD

ConvVitD

Arm Description

Oral nano form of the calciferol

Conventional oral calciferol

Outcomes

Primary Outcome Measures

Vitamin D (25OHD) blood level

Change of the D vitamin level after follow-up interval

Secondary Outcome Measures

Full Information

NCT ID

NCT05733117

First Posted

September 25, 2022

Last Updated

February 16, 2023

Sponsor

Tomas Bata Hospital, Czech Republic

Collaborators

Faculty Hospital Kralovske Vinohrady

1. Study Identification

Unique Protocol Identification Number

NCT05733117

Brief Title

Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tomas Bata Hospital, Czech Republic

Collaborators

Faculty Hospital Kralovske Vinohrady

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Substitution

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NanoVitD

Arm Type

Active Comparator

Arm Description

Oral nano form of the calciferol

Arm Title

ConvVitD

Arm Type

Active Comparator

Arm Description

Conventional oral calciferol

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

cholecalciferol

Primary Outcome Measure Information:

Title

Vitamin D (25OHD) blood level

Description

Change of the D vitamin level after follow-up interval

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vladimír Kojecký

Phone

+420577552512

kojecky@bnzlin.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vladimír Kojecký, MD

Organizational Affiliation

Tomas Bata Hospital, Czech Republic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty Hospital Kralovske Vinohrady

City

Prague

ZIP/Postal Code

10024

Country

Czechia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan Matous, MD

Phone

+420267163680

jan.matous1@fnkv.cz

Facility Name

ThomasBH

City

Zlín

ZIP/Postal Code

76001

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vladimír Kojecký, MD

Phone

+420577552510

kojecky@bnzlin.cz

First Name & Middle Initial & Last Name & Degree

Vladimir Kojecky

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

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