Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

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: Vitamin D Substitution
• Intervention / Treatment: Drug: Vitamin D

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

• Study Contact: Name: Vladimír Kojecký; Phone Number: +420577552512; Email: kojecky@bnzlin.cz

Study Locations

• Czechia
  • Prague, Czechia, 10024
    • Not yet recruiting
    • Faculty Hospital Královské Vinohrady
  • Zlín, Czechia, 76001
    • Recruiting
    • ThomasBH
    • Principal Investigator: Vladimir Kojecky
    • Contact: Vladimír Kojecký, MD; Phone Number: +420577552510; Email: kojecky@bnzlin.cz

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Change of the D vitamin level after follow-up interval	4 months

Collaborators and Investigators

• 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

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: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• 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