2023-05-11 12:31:18
Results of a randomized controlled study show that high-dose vitamin D does not prevent relapses in patients with relapsing, remitting multiple sclerosis (RRMS). However, at least one expert believes that the study’s exclusion criteria may have been too broad [1].
Early evidence from observational studies
The research into vitamin D to prevent MS flare-ups is based on older observational studies of patients who already had higher levels of vitamin D in their blood and were less likely to develop MS, the study leader said Prof. Dr. Ellen Mowry across from Medscape. She is Professor of Neurology at Johns Hopkins University School of Medicine in Baltimore, Maryland.
Recent research that has shown participants vitamin D as a therapeutic option for MS “has been disappointing, as the vitamin D had minimal effect,” she said. “While we were excited by the early data suggesting an important impact of vitamin D on MS. But it is imperative that these association studies are followed by the clinical gold standard that we have here.” Specifically, it means randomized, controlled clinical trials.
No difference in risk of recurrence
Between 2012 and 2019, exactly 172 participants aged between 18 and 50 with RRMS took part in the multicentre, clinical phase 3 study “Vitamin D to Ameliorate MS” (VIDAMS). Inclusion criteria included subjects with 1 or more clinical episodes of MS in the past year and at least 1 brain lesion on MRI in the past year. There were also people with 2 or more clinical episodes in the past year. Participants were also required to have a score of ≤ 4 on the Kurtzke Expanded Disability Status Scale.
A total of 83 participants were randomly selected to take low-dose vitamin D3 (600 IU/day) and 89 to take high-dose vitamin D3 (5,000 IU/day). Each participant took the vitamin along with a tablet of glatiramer acetate. This synthetically produced polypeptide is prescribed for RRMS; the exact mechanism of action is unknown.
Every 12 weeks, physicians measured the participants’ serum 25(OH)D levels, and every 24 weeks, a battery of movement and coordination tests and 2 clinical 3T brain MRI scans were performed to detect lesions.
After 96 weeks, researchers found no difference in risk of recurrence between the high and low dose groups (p=0.57). There were also no differences in the MRI results.
Have researchers made the exclusion criteria too broad?
Prof. Dr. Alberto AscherioProfessor of Epidemiology and Nutrition at Harvard TH Chan School of Public Health in Boston, Massachusetts, commented on the results for Medscape. He said a key principle for recommending vitamin supplements is that they are only of benefit to individuals with vitamin deficiencies. In the study, however, the researchers “excluded patients with vitamin D deficiency (25(OH)D<15 ng/ml, which corresponds to 37.5 nmol/l)".
Most notably, the average baseline level of 25(OH)D was around 30 ng/mL (75 nmol/L), which is considered to be an adequate level. The US Institute of Medicine (IOM) rates 20 ng/ml, i.e. 50 nmol/l, as a sufficient level. Ascherio: “It would be a serious mistake to conclude from this study (or any of the earlier studies) that vitamin D supplementation is not important in MS patients.”
It would be a serious mistake to conclude from this study (or any of the earlier studies) that vitamin D supplementation is not important in MS patients.
He added that many MS patients have serum vitamin D levels less than 20 ng/mL (50 nmol/L) and that this has been the median serum level in studies of MS patients in Europe. “These patients would almost certainly benefit from moderate doses of vitamin D supplements or reasonable exposure to UV light,” Ascherio points out. “Most likely, even patients with adequate but suboptimal 25(OH)D levels (between 20 and 30 ng/mL or 50 and 75 nmol/L) would benefit from an increase.”
The article originally appeared on www.medscape.com. He was made by Dr. Petra Kittner for Univadis.de translated.
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