ACTRIMS 2023: High-dose vitamin D doesn’t reduce MS activity: Trial
Rates of change for lesions, brain atrophy were compared against low dose
Taking high-dose vitamin D supplements as an add-on to standard MS treatment doesn’t reduce the risk of inflammatory disease activity for people with relapsing-remitting multiple sclerosis (RRMS), according to data from a clinical trial.
The findings “suggest that prescribing higher doses of vitamin D for purposes of modifying the RRMS disease course may not be beneficial,” researchers said.
The results were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, Feb. 23-25 in San Diego, in the poster, “High Dose Vitamin D3 Supplementation Does Not Reduce Imaging Measures of Disease Activity in Relapsing Remitting Multiple Sclerosis in a Randomized Controlled Trial.”
Vitamin D is a nutrient with many important roles in the body, including helping to maintain bone health and regulating the activity of the immune system. Studies have suggested that low levels of vitamin D may be a risk factor for multiple sclerosis (MS), but there’s little data on whether taking supplements of it might benefit people who already have the neurological disorder.
Johns Hopkins University sponsored a Phase 3 clinical trial, called Vitamin D to Ameliorate MS, or VIDAMS (NCT01490502), to study the effects of vitamin D supplementation on MS patients. It enrolled adults with RRMS, ages 18 to 50, who were being treated with glatiramer acetate (sold as Copaxone and generics). Most were newly diagnosed and started this therapy when they entered the trial.
“When we started the trial in 2012, there weren’t a whole lot of choices [for MS treatment], so it [glatiramer acetate] was a very popular platform therapy to start,” said Sandra Cassard, a researcher at Johns Hopkins School of Medicine who presented the poster at ACTRIMS.
Effects of high-dose vitamin D on MS
Participants were randomly assigned to a low dose of vitamin D, 600 International Units (IU)/day — about the typical recommended intake — or a high dose of 5,000 IU/day, for a total of 96 weeks, or about two years.
The trial specifically used supplements containing vitamin D3, which is a form that’s active in the body.
The lower dose “was, in effect, our placebo, because we didn’t expect to see a big change [in MS activity] with getting 600 IUs per day,” Cassard said.
The average vitamin D levels in the blood of participants in both groups upon entering the trial were were just under 30 nanograms/mL (ng/mL), which are considered insufficient, according to guidelines from the Endocrine Society. Levels under 20 ng/mL are considered a vitamin D deficiency.
To be eligible, patients had to have blood vitamin D levels of 15 ng/mL or higher, a cutoff chosen because it’s considered unethical to enroll patients with severe deficiency in a trial where they might get a low dose.
The analysis included data for 139 trial participants, 65 on low-dose vitamin D and 74 on high-dose, who had available data from at least two MRI scans.
As expected, average vitamin D levels were generally stable over time in the low-dose group, but increased substantially in the high-dose group. By the end of the study, average levels were 30.3 ng/mL in the low-dose group and 54 ng/mL in those give the high dose.
These data show “that [participants] were taking their medication [and] it was doing what we expected it to do,” Cassard said.
The vitamin supplements were well tolerated overall. Two patients, one each in both groups, developed kidney stones that were considered possibly related to the supplements.
Researchers compared rates of change for several measures of MS-related radiological activity, including the appearance of new or enlarging lesions, active inflammatory lesions, and rates of brain atrophy (shrinkage), both for the whole brain and for specific types of brain tissue.
There was no statistically significant difference between the high- and low-dose vitamin D groups across these measures, results showed. Data also showed no significant differences between the two groups regarding relapse activity or disability progression, Cassard said.
“The VIDAMS trial provides evidence that high dose vitamin D3 supplementation, as add-on to [glatiramer acetate] therapy, does not reduce imaging measures of disease activity in established RRMS,” the researchers said.
While the trial specifically tested vitamin D supplements as an add-on to glatiramer acetate, Cassard said she expects the results would be similar with any MS disease-modifying therapy.
“I think [with] a higher efficacy therapy, you wouldn’t expect to see a benefit of supplementation. I think a platform therapy that’s of moderate efficacy [such as glatiramer acetate] is one that would likely show a difference if there’s going to be a difference,” she said, noting that other trials testing vitamin D as an add-on to interferon therapies have found similarly negative results.
Note: The Multiple Sclerosis News Today team is providing in-depth coverage of the ACTRIMS Forum 2023 Feb. 23-25. Go here to see the latest stories from the conference. Follow along on Facebook, Twitter, and Instagram for live updates using the hashtag #actrims2023.