Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

February 16, 2023 updated by: Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 10024
        • Not yet recruiting
        • Faculty Hospital Kralovske Vinohrady
      • Zlín, Czechia, 76001
        • Recruiting
        • ThomasBH
        • Principal Investigator:
          • Vladimir Kojecky
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NanoVitD
Oral nano form of the calciferol
Drug: Vitamin D
cholecalciferol
Active Comparator: ConvVitD
Conventional oral calciferol
Drug: Vitamin D
cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D (25OHD) blood level
Time Frame: 4 months
Change of the D vitamin level after follow-up interval
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomas Bata Hospital, Czech Republic

Collaborators

Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: Vladimír Kojecký, MD, Tomas Bata Hospital, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K092022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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