Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis
NCT ID: NCT01753375
Last Updated: 2012-12-20
Study Results
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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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2013-01-31
2014-10-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Vitamin D3
Administered orally on weekly basis
Vitamin D3
Vitamin D3 given as 50000 IU orally on weekly basis
Placebo
To be administered orally on weekly basis
Placebo
Placebo to be given orally on weekly basis
Interventions
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Vitamin D3
Vitamin D3 given as 50000 IU orally on weekly basis
Placebo
Placebo to be given orally on weekly basis
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Connective tissue disease (SLE, Sjogren's disease)
* Endocrine disease (hyperthyroidism, hyperparathyroidism)
* Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency
18 Years
55 Years
ALL
No
Sponsors
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AlJohara M AlQuaiz, M.D.
OTHER
Responsible Party
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AlJohara M AlQuaiz, M.D.
Executive Director of "Princess Nora Chair for Women Health Research" , Associate Professor and Consultant Family Physician, Department of Family and Community Medicine
Principal Investigators
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AlJohara M AlQuaiz, M.D
Role: PRINCIPAL_INVESTIGATOR
King Saud University- Medical college
Locations
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Multiple Sclerosis clinic, Department of Neurology, King Khalid Hospital
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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References
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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.
Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc. 2000 Nov;59(4):531-5. doi: 10.1017/s0029665100000768.
Munger 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.
Kimball 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.
Shaygannejad 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.
Jagannath 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.
Burton 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.
Other Identifiers
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E12816
Identifier Type: -
Identifier Source: org_study_id