This study reports the trial of vitamin D + beta interferon verses vitamin D and the vitamin D trial fails. In my time capsule, I had this one as a fail too, just as the WORMS study failed to meet its endpoint too.
You say I am saying this, after the event, which is true…but my time capsule for microbiome trials were planted about three years ago and they say the same thing.
Academics are showing themselves to be lemmings and they often follow dogma. So a trial in arthritis is followed by trials in diabetes, MS disease X and Y and vice versa. The charties feed the lemmings to fund the trials. However, people pay no attention to me, I have been arguing for combiation trials for neuroprotection and repair that deal with the inflammations as a base, so often my face has turned into the colour a Smurf. Mark my words, trials will be announced and they will be single chemical studies that don’t deal with the underlying infiltration.
Prof G may come back to give his opinion. After all he has an interest in vitamin D
We have loads of trials to wait for them to report, but I rather think if you have an effect you get a side-effect. No side-effect..No effect?. This does not mean vitamin D is not important, as the information suggests it may be involved in susceptibility, but the trials should not be in established MS, rather before MS occurs. This may mean treating pregnant mums. However it is importat that you are vitamin D replete to save bone health.
Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon β-1a. Hupperts R, Smolders J, Vieth R, Holmøy T, Marhardt K, Schluep M, Killestein J, Barkhof F, Beelke M, Grimaldi LME; SOLAR Study Group. Neurology. 2019. pii: 10.1212/WNL.0000000000008445.
OBJECTIVE: In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D3 in patients with RRMS.
METHODS: Eligible patients with RRMS treated with SC interferon-β-1a (IFN-β-1a) 44 μg 3 times weekly and serum 25(OH)D levels <150 nmol/L were included. From February 15, 2011, to May 11, 2015, 229 patients were included and randomized 1:1 to receive SC IFN-β-1a plus placebo (n = 116) or SC IFN-β-1a plus oral high-dose vitamin D3 14,007 IU/d (n = 113). The revised primary outcome was the proportion of patients with no evidence of disease activity (NEDA-3) at week 48.
RESULTS:At 48 weeks, 36.3% of patients who received high-dose vitamin D3 had NEDA-3, without a statistically significant difference in NEDA-3 status between groups (placebo 35.3%; odds ratio 0.93; 95% confidence interval [CI] 0.53-1.63; p = 0.80). Compared with placebo, the high-dose vitamin D3 group had better MRI outcomes for combined unique active lesions (incidence rate ratio 0.68; 95% CI 0.52-0.89; p = 0.0045) and change from baseline in total volume of T2 lesions (difference in mean ranks: -0.074; p = 0.035).
CONCLUSIONS: SOLAR did not establish a benefit for high-dose vitamin D3 as add-on to IFN-β-1a, based on the primary outcome of NEDA-3, but findings from exploratory outcomes suggest protective effects on development of new MRI lesions in patients with RRMS.
CLINICALTRIALSGOV IDENTIFIER: NCT01285401.