Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis
Recruitment status was: Not yet recruiting
|Multiple Sclerosis||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Role of Vitamin D on the Relapse Rate of Multiple Sclerosis|
- Relapse rate in patients with Multiple Sclerosis [ Time Frame: 12 months ]
- Improvement in the expanded disability status scores after receiving vitamin D3 [ Time Frame: 12 months ]
|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)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753375
|Contact: Prof. Abdulkader Daif, M.Demail@example.com|
|Multiple Sclerosis clinic, Department of Neurology, King Khalid Hospital|
|Riyadh 11321, Saudi Arabia, 231831|
|Principal Investigator:||AlJohara M AlQuaiz, M.D||King Saud University- Medical college|