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Vitamin D Substitution During Winter Time

NCT ID: NCT02958501

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-31

Brief Summary

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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)

Detailed Description

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Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.

Conditions

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Vitamin D Substitution

Keywords

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Vitamin D Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IU/Day

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

Group Type ACTIVE_COMPARATOR

Colecalciferol

Intervention Type DRUG

Drug

IU/Kg/Day

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

Group Type ACTIVE_COMPARATOR

Colecalciferol

Intervention Type DRUG

Drug

Interventions

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Colecalciferol

Drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with inflammatory bowel disease

Exclusion Criteria

* Liver disease
* Renal disease
* Hypercalcemia
* Hyperparathyreoidism
* Chronic pancreatitis
* Concomitant vitamin D medication
* Pregnancy
* Sarcoidosis
* Malignancy
* Inability to obtain valid data from subject
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nemocnice T.Bati, Zlin

UNKNOWN

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role lead

Responsible Party

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MUDr. Jan Matous

Jan Matous, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jan Matous, MD

Role: CONTACT

Phone: +420267163680

Email: [email protected]

Vladimir Kojecky, MD,PhD

Role: CONTACT

Phone: +420577552512

Email: [email protected]

Other Identifiers

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DV1607

Identifier Type: -

Identifier Source: org_study_id