Multiple SclerosisPhase 3MSVitNCT01768039
Vitamine D in Multiple Sclerosis
A Phase 3 study testing Vitamin D in people with Multiple Sclerosis, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial summary
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial. They will randomly assigned to placebo or vitamin D treatment group. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIran
- Study dates
- Mar 2013to Oct 2014
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI:18-30kg/m2
- caucasian race
- Relapsing remitting multiple sclerosis
- treatment with interferon beta
Who cannot join
- Recent vitamin D supplement therapy
- Restricted fat diet
- nephrolithiasis in recent 5 years
- Past history of hyperparathyroidism, sarcoidosis, cancer
- Past history of hepatic disease
- Past history of gastrointestinal disease
Show all 19Show fewer
- Past history of mycobacterial infection
- Past history of hypercalcemia and hypercalciuria
- serum creatinine>1.5
- Smoking, drug abuse and corticosteroid therapy in recent year
- treatment with thiazides or other drugs that inhibit vitamin D absorption
- Disease attack in recent 2 months
- Serum Ca>2.6mm0l/L
- Serum 25(OH)D>85mmol/L
- hypersensitivity to cholecalciferol
- Past history of heart disease
- Major depression
- Uncontrolled hypertension (BP>180/110)
- Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mazandaran University of medical sciences
Sari, Mazandaran
Mahmoud Abedini, MD
About this study
Official title: Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.
They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.
- Conditions
- Multiple Sclerosis
- Being tested
- Vitamin D, Placebo
- Keywords
- Multiple sclerosis, Vitamin D, EDSS, ARR
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | treatment with weekly 50000IU vitamin D Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Treatment with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded disability state scale score (EDSS)
Measured: Changes in EDSS from baseline to 6 months
Secondary outcomes (1)
Annual relapse rate(ARR)
Measured: Changes in ARR from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abedini, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768039
- Sponsor's protocol ID
- MS-1191
- Acronym
- MSVit
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01768039
- Acronym / sponsor ID
- MSVit / MS-1191
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Vitamin D, EDSS, ARR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 15 Jan 2013 (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.
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.
They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin Dtreatment with weekly 50000IU vitamin D |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI:18-30kg/m2
- caucasian race
- Relapsing remitting multiple sclerosis
- treatment with interferon beta
Key exclusion criteria (19 listed)
- Recent vitamin D supplement therapy
- Restricted fat diet
- nephrolithiasis in recent 5 years
- Past history of hyperparathyroidism, sarcoidosis, cancer
- Past history of hepatic disease
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 |
|---|---|---|
| Vitamin D | Drug | Vitamin D |
| Placebo | Drug | Placebo |
Primary outcome
Expanded disability state scale score (EDSS)
Time frame: Changes in EDSS from baseline to 6 months
1 secondary outcome
Annual relapse rate(ARR)
Time frame: Changes in ARR from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Multiple Sclerosis, run by Mazandaran University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 19 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 15 Jan 2013. 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Mahmoud Abedini, MD (01513243158, mahmoudabedini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded disability state scale score (EDSS) (time frame: Changes in EDSS from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2013.