Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Phase 4

Recruiting

• Conditions: Vitamin D Substitution
• Interventions: Drug: Vitamin D

• Registration Number: NCT05733117
• Lead Sponsor: Tomas Bata Hospital, Czech Republic

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.

Study Timeline

• Study First Submitted: 2022-09-25
• Study Start: 2022-10-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-04-30
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ConvVitD	Vitamin D	Conventional oral calciferol
NanoVitD	Vitamin D	Oral nano form of the calciferol

Primary Outcome Measures

Name	Time	Method
Vitamin D (25OHD) blood level	4 months	Change of the D vitamin level after follow-up interval

Trial Locations

Locations (2)

Faculty Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czechia

ThomasBH; 🇨🇿 Zlín, Czechia