Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients

Treatment tested

• Cholecalciferol

  Vitamin D receptor agonist

Other measures (4)

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.

This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.