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Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Colecalciferol
Placebo capsules
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 to 55 years
  • remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month
  • EDSS (expanded disability statsu scale) ≤ 5
  • no neutralising antibodies to INFB as measured by indirect MxA test
  • prepared and considered to follow the protocol
  • using appropriate contraceptive methods (women of childbearing potential)
  • has given informed consent

Exclusion Criteria:

  • serum calcium >2.6 mmol/L
  • serum 25(OH)D2 (kalsidiol) > 85 nmol/L
  • presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L)
  • pregnancy or unwillingness to use contraception
  • alcohol or drug abuse
  • use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
  • current use of other immunomodulatory therapy than interferon-beta-1b
  • known allergy to cholecalciferol or arachis oil (peanuts)
  • therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry
  • any condition predisposing to hypercalcaemia (such as any type of cancer)
  • sarcoidosis
  • nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit
  • significant hypertension (Blood Pressure <180/110 mmHg)
  • hyperthyroidism, or hypothyroidism in the year before the study began
  • a history of nephrolithiasis during the previous five years
  • cardiac insufficiency or significant cardiac dysrhythmia
  • unstable or advanced ischaemic heart disease
  • has suffered a major depression

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D

Identically appearing once weekly peroral capsules

Outcomes

Primary Outcome Measures

Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months

Secondary Outcome Measures

Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation

Full Information

First Posted
April 19, 2011
Last Updated
May 18, 2011
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT01339676
Brief Title
Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Official Title
Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turku

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identically appearing once weekly peroral capsules
Intervention Type
Drug
Intervention Name(s)
Colecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Intervention Description
Identically appearing once weekly peroral placebo capsules
Primary Outcome Measure Information:
Title
Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months
Time Frame
one year
Secondary Outcome Measure Information:
Title
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 55 years remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month EDSS (expanded disability statsu scale) ≤ 5 no neutralising antibodies to INFB as measured by indirect MxA test prepared and considered to follow the protocol using appropriate contraceptive methods (women of childbearing potential) has given informed consent Exclusion Criteria: serum calcium >2.6 mmol/L serum 25(OH)D2 (kalsidiol) > 85 nmol/L presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L) pregnancy or unwillingness to use contraception alcohol or drug abuse use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses current use of other immunomodulatory therapy than interferon-beta-1b known allergy to cholecalciferol or arachis oil (peanuts) therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry any condition predisposing to hypercalcaemia (such as any type of cancer) sarcoidosis nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit significant hypertension (Blood Pressure <180/110 mmHg) hyperthyroidism, or hypothyroidism in the year before the study began a history of nephrolithiasis during the previous five years cardiac insufficiency or significant cardiac dysrhythmia unstable or advanced ischaemic heart disease has suffered a major depression
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22362918
Citation
Soilu-Hanninen M, Aivo J, Lindstrom BM, Elovaara I, Sumelahti ML, Farkkila M, Tienari P, Atula S, Sarasoja T, Herrala L, Keskinarkaus I, Kruger J, Kallio T, Rocca MA, Filippi M. A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon beta-1b in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 May;83(5):565-71. doi: 10.1136/jnnp-2011-301876. Epub 2012 Feb 22.
Results Reference
derived

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Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

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