Multiple SclerosisPhase 4NCT01339676
Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
A Phase 4 study testing Colecalciferol in people with Multiple Sclerosis, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Colecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Colecalciferol, Placebo capsules
- Keywords
- Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColecalciferolDrug
Also called Vitamin D
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
Placebo capsulesDrug
Identically appearing once weekly peroral placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Drug: Colecalciferol |
| 2 | Placebo comparator | Identically appearing once weekly peroral capsules Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startMar 2008
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339676
- Sponsor's protocol ID
- 2007-001958-99
- Other IDs
- EudraCT 2007-001958-99
- Status last verified
- Apr 2011
- First submitted
- 19 Apr 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22362918
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
- ClinicalTrials.gov ID
- NCT01339676
- Acronym / sponsor ID
- 2007-001958-99
- Conditions
- Multiple Sclerosis
- Keywords
- Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ColecalciferolOnce 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 |
| 2 | Placebo comparator | Drug: Placebo capsulesIdentically appearing once weekly peroral capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColecalciferolAlso: Vitamin DOnce 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 | Drug | 1 |
| Placebo capsulesIdentically appearing once weekly peroral placebo capsules | Drug | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Derived from this study: PubMed 22362918Soilu-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colecalciferol in people with Multiple Sclerosis, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.