Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by King Saud University
Sponsor:
Information provided by (Responsible Party):
AlJohara M AlQuaiz, M.D., King Saud University
ClinicalTrials.gov Identifier:
NCT01753375
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Role of Vitamin D on the Relapse Rate of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Relapse rate in patients with Multiple Sclerosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the expanded disability status scores after receiving vitamin D3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3
Administered orally on weekly basis
Dietary Supplement: Vitamin D3
Vitamin D3 given as 50000 IU orally on weekly basis
Placebo Comparator: Placebo
To be administered orally on weekly basis
Dietary Supplement: Placebo
Placebo to be given orally on weekly basis

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753375

Contacts
Contact: Prof. Abdulkader Daif, M.D 0966-0504205164 adaif@ksu.edu.sa

Locations
Saudi Arabia
Multiple Sclerosis clinic, Department of Neurology, King Khalid Hospital
Riyadh 11321, Saudi Arabia, 231831
Sponsors and Collaborators
AlJohara M AlQuaiz, M.D.
Investigators
Principal Investigator: AlJohara M AlQuaiz, M.D King Saud University- Medical college
  More Information

Publications:
Responsible Party: 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, King Saud University
ClinicalTrials.gov Identifier: NCT01753375     History of Changes
Other Study ID Numbers: E12816
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by King Saud University:
Multiple Sclerosis
Relapsing rate
Expanded disability status scale
Vitamin D3

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014