Oral Nano Vitamin D Supplementation Efficacy in Inflammat... | NCT05733117

Studies
Oral Nano Vitamin D Supplementation Efficacy in Inflammatory Bowel Disease

NCT05733117

Sponsor

Tomas Bata Hospital, Czech Republic

Status

Unknown status

Last Update Posted

Feb 17, 2023Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Vitamin D Substitution

Interventions

Vitamin D

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Sep 25, 2022

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2023

Last Update Posted Date

Feb 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vladimir Kojecky, MD, Ph.D., Head of dept. of internal medicine, Tomas Bata Hospital, Czech RepublicPrincipal Investigator

Lead Sponsor

Tomas Bata Hospital, Czech RepublicOTHER

Collaborators

Name	Class
Faculty Hospital Kralovske Vinohrady	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NanoVitD	Active Comparator	Oral nano form of the calciferol	Drug: Vitamin D
ConvVitD	Active Comparator	Conventional oral calciferol	Drug: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	cholecalciferol	ConvVitD NanoVitD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vladimír Kojecký	Contact	+420577552512		kojecky@bnzlin.cz

Overall Officials

Name	Affiliation	Role
Vladimír Kojecký, MD	Tomas Bata Hospital, Czech Republic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Hospital Kralovske Vinohrady	Not yet recruiting	Prague		10024	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided