Vitamin A (retinoic acid) in Multiple Sclerosis: Avoiding the Mistakes Made with Vitamin D

Background: This study will determine if higher levels vitamin A levels and normal vitamin D levels in conjunction with interferon-beta or glatiramer acetate disease modifying therapy treatments are associated with decreased MS severity at a 3 years. As the normal range for vitamin A levels is between 30 to 95 micrograms/dL, it is not clear whether lower levels are just as good as the higher range. Previous studies in other disease separated patients based on their vitamin A levels into 3-5 divisions based on a vitamin A level range (ie less than 29, 30-50, 51-70, 71-95, greater than 95). It is expected that patients levels do not fluctuate significantly from year to year and tend to remain within one group. We will measure the vitamin A levels every 3 months to determine if there was a change in the levels such that the patient has moved from their previous quintile group.  We will also measure retinol binding protein and serum beta-carotene levels as these influence the vitamin A level and prior studies utilized these measures. By measuring all three of these we will be able to better determine which marker of vitamin A status is best for future studies. Annually, we will take an average of the vitamin A levels and assign to a quintile group. 

Objectives: and Methods: Inclusion criteria will include, relapsing remitting patients with variable severity (we can further divide these patients into EDSS groups 1-3, 3.5-5.5, 6-7.5, greater or = to 8). A previous study demonstrated that EDSS changes in more severe RRMS (EDSS >4) patients had a greater change in rank in a 5 year period but also greater than 2 years. Because our patient population have an average EDSS in the slightly higher ranges (EDSS 4-6), it provides an ideal population of patients for a study of 3 years duration. Additionally, these patients must have a normal vitamin D level at the start of the study; if they are low they will be treated with vitamin D. Demographic data will be collected on patients with RRMS who are taking or started on either copaxone or an interferon-beta.Qualifying patients will be followed for a total of 3 years (with annual review of the data). In additional to the severity (EDSS score) being followed, we will record annualized relapse rate, MRI data, as well as an MRI study known as magnetization transfer (MTR) which has been used to determine remyelination in MS patients. This will provide data regarding the rate of remyelination in the MS patients in the various quintile groups of vitamin A. Previously, Vitamin A has been shown to improve myelination in the EAE model. 

Results: We expect to present preliminary results.

Conclusions: It is not known if remyelination is greater and progression is slower in the higher vitamin A level groups.