NCT02958501

Brief Summary

The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)

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
176

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

November 1, 2016

Last Update Submit

November 4, 2016

Conditions

Vitamin D Substitution

Keywords

Vitamin DInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in vitamin D blood level after follow-up interval

    Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.

    4 Months

Secondary Outcomes (1)

  • Change in vitamin D after follow-up interval according to weight

    4 Months

Study Arms (2)

IU/Day

ACTIVE COMPARATOR

This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight

Drug: Colecalciferol

IU/Kg/Day

ACTIVE COMPARATOR

This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight

Drug: Colecalciferol

Interventions

ColecalciferolDRUG

Drug

IU/DayIU/Kg/Day

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with inflammatory bowel disease

You may not qualify if:

  • Liver disease
  • 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 (1)

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Jan Matous, MD

CONTACT

+420267163680jan.matous1@fnkv.cz

Vladimir Kojecky, MD,PhD

CONTACT

+420577552512kojecky@bnzlin.cz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jan Matous, MD

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)