Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

Vitamin D Substitution Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733117
• Other study ID #: K092022
• Status: Recruiting
• Phase: Phase 4
• Start date: October 25, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2023
• Source: Tomas Bata Hospital, Czech Republic
• Contact: Vladimír Kojecký
• Phone: +420577552512
• Email: kojecky[@]bnzlin.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Vitamin D Substitution

Intervention

Drug:
• Vitamin D
cholecalciferol

Locations

Country	Name	City	State
Czechia	Faculty Hospital Kralovske Vinohrady	Prague
Czechia	ThomasBH	Zlín

Sponsors (2)

Lead Sponsor	Collaborator
Tomas Bata Hospital, Czech Republic	Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D (25OHD) blood level	Change of the D vitamin level after follow-up interval	4 months