Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-06-30

Brief Summary

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Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Verum (high dose)

verum arm receiving high dose Vitamin D oil

Group Type EXPERIMENTAL

Verum arm receiving Vitamin D oil

Intervention Type DRUG

oil: 20000 IU/g tablet: 400 IU/g every second day

Verum (low dose)

low dose arm receiving neutral oil and low dose of Vitamin D

Group Type EXPERIMENTAL

low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day

Intervention Type DRUG

neutral oil and a low dose of vitamin D

Interventions

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Verum arm receiving Vitamin D oil

oil: 20000 IU/g tablet: 400 IU/g every second day

Intervention Type DRUG

low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day

neutral oil and a low dose of vitamin D

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Age between 18 and 65 at randomization
* Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
* EDSS ≤ 6,0
* Stable immunomodulatory treatment for at least 3 months
* Sufficient birth control (Pearl-Index \<1) and negative pregnancy test at screening/randomization

Exclusion Criteria

* Any other MS-course than RRMS
* Treatment with high dose vitamin D within 6 months prior to randomization
* Patients who have received over the last three months prior to randomization, an immunomodulatory therapy with the exception of IFN-β1b (Betaferon ®)
* Any condition that could interfere with MRI or other study related investigation
* Intolerability to Gd-DTPA
* Hypersensitivity to the drug Colecalciferol
* Patients with sarcoidosis
* Presence or history of nephrolithiasis
* Pseudohypoparathyroidism
* Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following laboratory values:

* HB \<8.5 g / dl
* WBC \<2.5 / nl
* platelet count \<100/nl
* Creatinine clearance by Cockcroft-Gault formula: Cl \<110ml/min (male) and Cl \<95ml/min (female)
* AST / ALT\> 3.5 times higher than the upper reference value
* bilirubin\> 2.0 mg / dl
* hypercalcaemia\> 2.7 mmol / l
* calcium / creatinine ratio in urine\> 1
* Treatment with hydrochlorothiazide, digitoxin, digoxin, phenytoin, barbiturates
* Pregnancy or lactation period
* Participation in any clinical study within 3 months before or at any time during study
* Any medical, psychiatric or other condition that could interfere with the patient's ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No