Multiple SclerosisPhase 2NCT01753375
Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis
A Phase 2 study testing Vitamin D3 in people with Multiple Sclerosis, run by AlJohara M AlQuaiz, M.D. at 1 site in Saudi Arabia.
Trial summary
Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to… 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?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2013to Oct 2014
- Phase
- Phase 2
- 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 between 18-55 years
- Confirmed Multiple Sclerosis diagnosis according to McDonald criteria
- Stable neurological functioning for at least one month prior to study entry
- Expanded Disability Scale score (EDSS) less than <_4.0
- Must have had one clinical attack in past two years and at least one new silent T2 or gadolinium-enhancing lesion on MRI within the past one year.
- Willing to participate for the entire 52-week period
Who cannot join
- pregnant or nursing.
- Connective tissue disease (SLE, Sjogren's disease)
- Endocrine disease (hyperthyroidism, hyperparathyroidism)
- Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Multiple Sclerosis clinic, Department of Neurology, King Khalid Hospital
Riyadh, 231831
About this study
Official title: Role of Vitamin D on the Relapse Rate of Multiple Sclerosis
Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).
Read the detailed description
Study Objectives:
- To estimate the prevalence of vitamin D deficiency in Saudi Multiple Sclerosis(MS) patient coming to King Khalid hospital, multiple sclerosis clinic.
- To compare the difference in the relapse rate among Multiple Sclerosis patients who are taking vitamin D3 (50,000 IU per week) versus those who are not taking Vitamin D3 supplements.
- To assess and compare the improvement in the Expanded Disability Status scale and clinical symptoms among those who are taking vitamin D3 versus those who are on placebo
Study Design: A single centre, triple-blinded, parallel randomized placebo controlled trial.
Methods: All eligible patients with clinical definite MS will be assigned a computer-generated Identification number by the statistician and through randomization divided into two groups, one group receiving vitamin D3 (the intervention arm) and other getting placebo (the control arm). All patients will continue with their routine pre-intervention trial treatment for relapse and remission phases of multiple sclerosis. The first treatment group will receive 50,000 IU units of vitamin D3 per week . The control arm patients, instead of vitamin D3 will receive a placebo supplement that looks, smells and tastes the same as the vitamin D3 for 52 weeks. Compliance with the study treatment will be verified by asking the patients about missed doses and by counting used and unused bottles.
All patients will be asked questions related socio-demographic data, vitamin D related dietary products, physical activity questions, exposure to sunlight and variation according to season, use of sunscreen, body coverage when in sunlight and any previous treatment for Multiple Sclerosis, including any vitamin D supplements. Every follow up visit shall include documentation of complete neurologic and medical history and findings. This will be a triple-blinded trial. The patient, the treating physician and the statistician will be masked to the type of treatment each patient receives.Sealed envelopes containing the vitamin D3 or placebo are going to be handed over to the physician with the computer assigned number of the patient. At each follow-up visit all patients will be required to bring their envelopes along with empty/ filled bottles to assess their compliance with the treatment.
The treating physician will follow all the patients at set regular intervals: 0 (baseline), 4, 8, and 12 months to assess the relapses and the EDSS scores and also to check for any adverse effects arising because of the vitamin D3 supplements. Patients who are going to miss their appointment shall be contacted by the project staff to set another appointment in the subsequent week. All patients are going to be emphasized about the importance of these clinical visits and their compliance with the treatment. All patients will be evaluated by the same treating physician.
- Conditions
- Multiple Sclerosis
- Being tested
- Vitamin D3, Placebo
- Keywords
- Multiple Sclerosis, Relapsing rate, Expanded disability status scale, Vitamin D3
- 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 D3Dietary supplement
Vitamin D3 given as 50000 IU orally on weekly basis
PlaceboDietary supplement
Placebo to be given orally on weekly basis
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | Administered orally on weekly basis Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | To be administered orally on weekly basis Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate in patients with Multiple Sclerosis
Measured: 12 months
Secondary outcomes (1)
Improvement in the expanded disability status scores after receiving vitamin D3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlJohara M AlQuaiz, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AlJohara M AlQuaiz, M.D., King Saud University
- Investigators
- AlJohara M AlQuaiz, M.D, Principal investigator, King Saud University- Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753375
- Sponsor's protocol ID
- E12816
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cantorna MT, Hayes CE, DeLuca HF. 1,25-Dihydroxyvitamin D3 reversibly blocks the progression of relapsing encephalomyelitis, a model of multiple sclerosis. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7861-4. doi: 10.1073/pnas.93.15.7861.
PubMed 8755567Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc. 2000 Nov;59(4):531-5. doi: 10.1017/s0029665100000768.
PubMed 11115787Munger KL, Zhang SM, O'Reilly E, Hernan MA, Olek MJ, Willett WC, Ascherio A. Vitamin D intake and incidence of multiple sclerosis. Neurology. 2004 Jan 13;62(1):60-5. doi: 10.1212/01.wnl.0000101723.79681.38.
PubMed 14718698Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.
PubMed 17823429Shaygannejad V, Janghorbani M, Ashtari F, Dehghan H. Effects of adjunct low-dose vitamin d on relapsing-remitting multiple sclerosis progression: preliminary findings of a randomized placebo-controlled trial. Mult Scler Int. 2012;2012:452541. doi: 10.1155/2012/452541. Epub 2012 Apr 11.
PubMed 22567287Jagannath VA, Fedorowicz Z, Asokan GV, Robak EW, Whamond L. Vitamin D for the management of multiple sclerosis. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008422. doi: 10.1002/14651858.CD008422.pub2.
PubMed 21154396Burton JM, Kimball S, Vieth R, Bar-Or A, Dosch HM, Cheung R, Gagne D, D'Souza C, Ursell M, O'Connor P. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010 Jun 8;74(23):1852-9. doi: 10.1212/WNL.0b013e3181e1cec2. Epub 2010 Apr 28.
PubMed 20427749
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D on the Relapse Rate of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01753375
- Acronym / sponsor ID
- E12816
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Relapsing rate, Expanded disability status scale, Vitamin D3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AlJohara M AlQuaiz, M.D.University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 20 Dec 2012 (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.
Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).
Detailed description
Study Objectives:
- To estimate the prevalence of vitamin D deficiency in Saudi Multiple Sclerosis(MS) patient coming to King Khalid hospital, multiple sclerosis clinic.
- To compare the difference in the relapse rate among Multiple Sclerosis patients who are taking vitamin D3 (50,000 IU per week) versus those who are not taking Vitamin D3 supplements.
- To assess and compare the improvement in the Expanded Disability Status scale and clinical symptoms among those who are taking vitamin D3 versus those who are on placebo
Study Design: A single centre, triple-blinded, parallel randomized placebo controlled trial.
Methods: All eligible patients with clinical definite MS will be assigned a computer-generated Identification number by the statistician and through randomization divided into two groups, one group receiving vitamin D3 (the intervention arm) and other getting placebo (the control arm). All patients will continue with their routine pre-intervention trial treatment for relapse and remission phases of multiple sclerosis. The first treatment group will receive 50,000 IU units of vitamin D3 per week . The control arm patients, instead of vitamin D3 will receive a placebo supplement that looks, smells and tastes the same as the vitamin D3 for 52 weeks. Compliance with the study treatment will be verified by asking the patients about missed doses and by counting used and unused bottles.
All patients will be asked questions related socio-demographic data, vitamin D related dietary products, physical activity questions, exposure to sunlight and variation according to season, use of sunscreen, body coverage when in sunlight and any previous treatment for Multiple Sclerosis, including any vitamin D supplements. Every follow up visit shall include documentation of complete neurologic and medical history and findings. This will be a triple-blinded trial. The patient, the treating physician and the statistician will be masked to the type of treatment each patient receives.Sealed envelopes containing the vitamin D3 or placebo are going to be handed over to the physician with the computer assigned number of the patient. At each follow-up visit all patients will be required to bring their envelopes along with empty/ filled bottles to assess their compliance with the treatment.
The treating physician will follow all the patients at set regular intervals: 0 (baseline), 4, 8, and 12 months to assess the relapses and the EDSS scores and also to check for any adverse effects arising because of the vitamin D3 supplements. Patients who are going to miss their appointment shall be contacted by the project staff to set another appointment in the subsequent week. All patients are going to be emphasized about the importance of these clinical visits and their compliance with the treatment. All patients will be evaluated by the same treating physician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3Administered orally on weekly basis |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTo be administered orally on weekly basis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-55 years
- Confirmed Multiple Sclerosis diagnosis according to McDonald criteria
- Stable neurological functioning for at least one month prior to study entry
- Expanded Disability Scale score (EDSS) less than <_4.0
- Must have had one clinical attack in past two years and at least one new silent T2 or gadolinium-enhancing lesion on MRI within the past one year.
Key exclusion criteria (4 listed)
- pregnant or nursing.
- Connective tissue disease (SLE, Sjogren's disease)
- Endocrine disease (hyperthyroidism, hyperparathyroidism)
- Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency
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 D3Vitamin D3 given as 50000 IU orally on weekly basis | Dietary supplement | Vitamin D3 |
| PlaceboPlacebo to be given orally on weekly basis | Dietary supplement | Placebo |
Primary outcome
Relapse rate in patients with Multiple Sclerosis
Time frame: 12 months
1 secondary outcome
Improvement in the expanded disability status scores after receiving vitamin D3
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Background: PubMed 8755567Cantorna MT, Hayes CE, DeLuca HF. 1,25-Dihydroxyvitamin D3 reversibly blocks the progression of relapsing encephalomyelitis, a model of multiple sclerosis. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7861-4. doi: 10.1073/pnas.93.15.7861.
- Background: PubMed 11115787Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc. 2000 Nov;59(4):531-5. doi: 10.1017/s0029665100000768.
- Background: PubMed 14718698Munger KL, Zhang SM, O'Reilly E, Hernan MA, Olek MJ, Willett WC, Ascherio A. Vitamin D intake and incidence of multiple sclerosis. Neurology. 2004 Jan 13;62(1):60-5. doi: 10.1212/01.wnl.0000101723.79681.38.
- Background: PubMed 17823429Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.
- Background: PubMed 22567287Shaygannejad V, Janghorbani M, Ashtari F, Dehghan H. Effects of adjunct low-dose vitamin d on relapsing-remitting multiple sclerosis progression: preliminary findings of a randomized placebo-controlled trial. Mult Scler Int. 2012;2012:452541. doi: 10.1155/2012/452541. Epub 2012 Apr 11.
- Background: PubMed 21154396Jagannath VA, Fedorowicz Z, Asokan GV, Robak EW, Whamond L. Vitamin D for the management of multiple sclerosis. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008422. doi: 10.1002/14651858.CD008422.pub2.
- Background: PubMed 20427749Burton JM, Kimball S, Vieth R, Bar-Or A, Dosch HM, Cheung R, Gagne D, D'Souza C, Ursell M, O'Connor P. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010 Jun 8;74(23):1852-9. doi: 10.1212/WNL.0b013e3181e1cec2. Epub 2010 Apr 28.
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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.
AlJohara M AlQuaiz, M.D principal investigator
King Saud University- Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Multiple Sclerosis, run by AlJohara M AlQuaiz, M.D. at 1 site in Saudi Arabia.
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 6 inclusion and 4 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 20 Dec 2012. 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 Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Prof. Abdulkader Daif, M.D (0966-0504205164, adaif@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate in patients with Multiple Sclerosis (time frame: 12 months). 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 NCT01753375, which also lists 7 linked publications.
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 20 Dec 2012.