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Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01753375
Recruitment Status : Unknown
Verified December 2012 by AlJohara M AlQuaiz, M.D., King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2012
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
AlJohara M AlQuaiz, M.D., King Saud University

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 20, 2012
Last Update Posted Date December 20, 2012
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
Relapse rate in patients with Multiple Sclerosis [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
Improvement in the expanded disability status scores after receiving vitamin D3 [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis
Official Title  ICMJE Role of Vitamin D on the Relapse Rate of Multiple Sclerosis
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    Vitamin D3 given as 50000 IU orally on weekly basis
  • Dietary Supplement: Placebo
    Placebo to be given orally on weekly basis
Study Arms  ICMJE
  • Active Comparator: Vitamin D3
    Administered orally on weekly basis
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo
    To be administered orally on weekly basis
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnant or nursing.
  • Connective tissue disease (SLE, Sjogren's disease)
  • Endocrine disease (hyperthyroidism, hyperparathyroidism)
  • Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753375
Other Study ID Numbers  ICMJE E12816
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AlJohara M AlQuaiz, M.D., King Saud University
Study Sponsor  ICMJE AlJohara M AlQuaiz, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AlJohara M AlQuaiz, M.D King Saud University- Medical college
PRS Account King Saud University
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP