NCT05733117

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

September 25, 2022

Last Update Submit

February 16, 2023

Conditions

Vitamin D Substitution

Outcome Measures

Primary Outcomes (1)

  • Vitamin D (25OHD) blood level

    Change of the D vitamin level after follow-up interval

    4 months

Study Arms (2)

NanoVitD

ACTIVE COMPARATOR

Oral nano form of the calciferol

Drug: Vitamin D

ConvVitD

ACTIVE COMPARATOR

Conventional oral calciferol

Drug: Vitamin D

Interventions

Vitamin DDRUG

cholecalciferol

ConvVitDNanoVitD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The inflammatory bowel disease patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

NOT YET RECRUITING

ThomasBH

Zlín, 76001, Czechia

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vladimír Kojecký, MD

    Tomas Bata Hospital, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimír Kojecký

CONTACT

+420577552512kojecky@bnzlin.cz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of dept. of internal medicine

Study Record Dates

First Submitted

September 25, 2022

First Posted

February 17, 2023

Study Start

October 25, 2022

Primary Completion

April 30, 2023

Study Completion

January 1, 2024

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(2)