Daily high dose vitamin D has been a treatment of choice for many people with multiple sclerosis, more specifically a few pockets of patients who follow some physicians in certain places in the world, such as São Paulo. The complete package these physicians and patients use is vitamin D enough to keep the blood level frankly above the normal, and a diet that will avoid toxic effects, specially in the kidneys. Although there has never been any evidence that this package functions at all as therapy for multiple sclerosis, this current of thought was supported by a series of related scientific facts. It was found in the past decade or so that people with multiple sclerosis have a deficiency of vitamin D in their blood, which is inheritted from the family, that is, genetic. Furthermore, it comes more frequently in people with MS. Third, it needs to corrected.
As a result of these facts, it became clinical reality that people with multiple sclerosis need to have their vitamin D checked in the blood, and kept at the top of normal levels. Vitamin D has been established as an immune item rather than a standard vitamin. The idea that people with their vitamin D well looked after will have a better prognosis of multiple sclerosis became solid. This of course rang bells in the minds of most people with multiple sclerosis, who had enough difficulty accepting they had this strange disease. For most people in the MS community, linking vitamin D and the sun with their MS was easy and automatic. Treating such a terrible disease with careful sun exposure and a vitamin makes most people quite happy. It is a marvellous solution for a horrible problem.
It is common knowledge that vitamin D is in fact cholecalciferol (D3) and ergocalciferol (D2). What is measured in the blood is 25 (OH) D cholecalciferol. The serum concentration recommended internationally is 30 ng/ml. Toxicity is above 150 ng/ml.
The package offered by some physicians, of very high daily doses of vitamin D with the diet to avoid hypercalcemia and renal toxicity was never proven by any scientific fact, or even by peripheral science. And now comes strong evidence to the contrary.
Raymond Hupperts and the Solar Study Group. Neurology 2019, 93:e1906-e1916
This was a study in 229 patients with relapsing and remitting multiple sclerosis who were already on treatment with interferon beta-1ª. It was carried out at 40 centers across 11 countries in Europe, between 2011-2015. Patients who were included were on 44ug interferon weekly, and had serum 25-hydroxyvitamin D below 60 ng/ml. It is a strong study from the methodological point of view. There are enough patients for good statistics, and they spread out among various services and countries, so the results are not the idea of one group. Furthermore, the study was double-blind. Without knowledge of health professionals or of patients, people were treated with identical placebo or active 14007 IU daily vitamin D3 supplementation.
Patients were stratified according to sex, body mass index and relapse frequency. Those are risk factors for different prognosis of MS. The subjects were monitored for 48 weeks – 4 years! That is a very satisfactory period for any study on experimental therapeutics. To finalize, very high standards of clinical outcome were chosen. People with no relapses, no disability progression and no new gadolinum enhancing lesions on MRI were regarded as NEDA-3. These are patients with no evidence of disease activity. Disease completely controlled. NEDA-3 has been considered the gold standard in the aim of treatment of multiple sclerosis.
There was no difference in NEDA-3 status between the vitamin D and placebo groups (p=0,8). So, the conclusion is simple: Daily high dose vitamin D has no place in the treatment of multiple sclerosis. The authors found a smal effect on a combined MRI measure of new lesions, but that may be statistical noise. Theory of statistics teaches that you should not use many measurements, because the chance of finding false positives or false negatives increases with the number of outcomes measured.
Dr Paulo Bittencourt