Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring cognitive performance, vitamin D3 replacement, Lebanon
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form
- Males/ Females
- Age ≥ 18 years old
- Have a definite diagnosis of RRMS as per the revised McDonald 2010 or CIS.
- Untreated or on any MS therapy
- Showed no clinical evidence of relapses during the past month and disease duration not greater than 10 years.
- Subjects who have a serum vitamin D level below 25 ng/ml
Exclusion Criteria:
- All subjects using drugs associated with hypercalcemia.
- Pregnant and with history of primary hyper PTH.
- Subjects with hypercalcemia, renal dysfunction, malignancy, or granulomatous disease, dementia, traumatic brain injury, diagnosis of epilepsy or history of seizure, psychiatric disease other than anxiety and depression, or are found to be suicidal on screening, or taking psychoactive medications other than antidepressants
- Subjects who have a serum vitamin D level above 25 ng/ml
- Subjects who have not done an MRI scan up to 3 months before or after the baseline visit.
- Subjects who have a history of kidney stones
- Subjects with malabsorption
- Individuals with history of alcohol abuse/dependence and/or substance use/abuse/dependence will also be excluded from the study. Men who consume more than 15 drinks per week and women who consume more than eight drinks per week will be considered excessive alcohol consumers and will be excluded from the study.
Sites / Locations
- Nehme & Therese Tohme Multiple Sclerosis CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
low dose vitamin D3 supplementation
high dose vitamin D3 supplementation
Patients in this group will take 800 IU daily dose of vitamin D supplementation. They will be kept on 800 IU for 6 months. If they still had low vitamin D at 3 months, they will be asked about their adherence to the supplement, the investigators will remind them to take it as prescribed, and the investigators will keep the 800 IU vitamin D supplement dose for another 3 months. If they were still deficient at 6 months, the investigators will switch them to 10,000 IU weekly dose.
Patients in this group will take 50,000 IU weekly dose of vitamin D supplementation. Patients who will reach normal serum vitamin D level, between 40-80 ng/ml, at 3 or 6 months will be asked to decrease their Vitamin D3 supplementation as follows: Those who will reach levels between 40-60ng/ml will be switched to 10,000 IU three times per week, and those who reach levels between 60-80 ng/ml will be switched to 10,000 IU once weekly. If they did not have any improvement in their levels of vitamin D at 3 or 6 months, they will be asked about their adherence to the supplement and the investigators will remind them to take it as prescribed and the investigators will keep them at the 50,000 IU weekly dose.