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Status unknownNCT05733117Updated Feb 17, 2023

Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

A Phase 4 interventional study of Vitamin D in Vitamin D Substitution, sponsored by Tomas Bata Hospital, Czech Republic. Status unknown at 2 sites in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by Tomas Bata Hospital, Czech Republic · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Vitamin D Substitution
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 438 are open to participants now.

This study's planned enrollment of 120 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Tomas Bata Hospital, Czech Republic is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The inflammatory bowel disease patients

Exclusion criteria

Exclusion Criteria:

  • Liver and renal disease
  • Hypercalcemia
  • Hyperparathyreoidism
  • Chronic pancreatitis
  • Concomitant vitamin D medication
  • Pregnancy
  • Sarcoidosis
  • Malignancy
  • Inability to obtain valid data from subject
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    NanoVitD

    Oral nano form of the calciferol

    Drug: Vitamin D

  • Active comparator
    ConvVitD

    Conventional oral calciferol

    Drug: Vitamin D

Interventions

  • DrugVitamin D

    cholecalciferol

06

What researchers measure

Primary outcomes

  1. Vitamin D (25OHD) blood level

    Change of the D vitamin level after follow-up interval

    Time frame: 4 months

07

Study locations

1 of 2 sites recruiting
  • Faculty Hospital Kralovske Vinohrady
    Prague, 10024, Czechia
    Not yet recruiting
  • ThomasBH
    Zlín, 76001, Czechia
    • Vladimír Kojecký, MD · Contact · kojecky@bnzlin.cz · +420577552510
    • Vladimir Kojecky · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05733117
Lead sponsor
Tomas Bata Hospital, Czech Republic
Collaborators
Faculty Hospital Kralovske Vinohrady
Responsible party
Vladimir Kojecky, MD, Ph.D. (Head of dept. of internal medicine, Tomas Bata Hospital, Czech Republic) — Principal investigator
First posted
Feb 17, 2023
Start date
Oct 25, 2022
Primary completion
Apr 30, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Feb 17, 2023

Study contacts

Vladimír Kojecký
Contact
kojecky@bnzlin.cz
+420577552512
Vladimír Kojecký, MD
principal investigator · Tomas Bata Hospital, Czech Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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