FDA Denies Health Claim for Vitamin D to Prevent MS Jan 2018
The Bayer Corporation petitioned the FDA to make the following claim
“Vitamin D may reduce the risk of multiple sclerosis (MS).”
Download the FDA response from Vitamin D Life
7 studies (see below) have found a ~2X less risk of Multiple Sclerosis for people with higher vitamin D levels
Vitamin D Life believes the claim that “Vitamin D may reduce the risk of multiple sclerosis (MS).” is valid
Table of contents
- FDA looked at only two observational studies
- Additional MS PREVENTION studies by Munger in Vitamin D Life
- The FDA did look at some small TREATMENT studies of MS with Vitamin D
- The FDA decided to ignore all meta-analyses of Vitamin D and Multiple Sclerosis
- Vitamin D Life believes that “Vitamin D may treat multiple sclerosis” would also be a valid claim
- See also Vitamin D Life
FDA looked at only two observational studies
that evaluated the association between serum vitamin D levels and MS risk
Strangely the FDA did not consider that the studies found any benefit
These 2 studies (and 5 others below) found: Higher Vitamin D ==> about a 2X decreased risk of MS
Munger et al., 2017
- 25-Hydroxyvitamin D deficiency and risk of MS among women in the Finnish Maternity Cohort
- Which is in Vitamin D Life Multiple Sclerosis risk a decade later was 2X higher if low vitamin D (12 ng vs 20 ng) – Sept 2017
Nielsen et al., 2017 Munger = coauthor
- Neonatal vitamin D status and risk of multiple sclerosis
- Which is in Vitamin D Life Multiple Sclerosis risk reduced 30 percent by each additional 10 ng of vitamin D at birth (1500 Danes) – Jan 2017
Additional MS PREVENTION studies by Munger in Vitamin D Life
- Multiple Sclerosis much more likely if low vitamin D during pregnancy –many studies
Munger observational study was discarded by FDA because it used Vitamin D levels, not vitamin D intake- pg 8 of response - Multiple Sclerosis 2X more likely if vitamin D deficient as a fetus decades earlier – May 2016
Munger observational study was discarded by FDA because it used Vitamin D levels, not vitamin D intake- pg 8 of response - Multiple Sclerosis risk reduced 40% in 92,000 women taking more than 400 IU of vitamin D – 2004
Munger observational study was not commented on by the FDA response
Perhaps because the Vitamin D was part of a multi-vitamin, and the reduced MS might have been due to some other ingredient
Note: The 2004 study commented on this possibility, and stated that future studies were to be based on Vitamin D levels, which the FDA later rejected - A gestational dose of vitamin D per day keeps the MS doctor away (2X reduction) – Nov 2016
Munger observational study perhaps discarded by FDA because it used Vitamin D levels, not vitamin D intake - Multiple Sclerosis 60 percent less likely in those with more than 40 ng of vitamin D – 2006
Munger observational study perhaps discarded by FDA because it used Vitamin D levels, not vitamin D intake
The FDA seems to ignore the fact that a person can increase their Vitamin D blood levels with Vitamin D supplements
The FDA did look at some small TREATMENT studies of MS with Vitamin D
Wonder why did the FDA looked at treatment studies to make a statement about prevention
- None of the studies were large enough to show statistical significance (typically fewer than 40 people)
- None of the studies used even a fraction of what is needed to “cure” multiple sclerosis
Burton et al., 2010
- A phase I/11 dose-escalation trial of vitamin D3 and calcium in multiple sclerosis
- Small trial did not have enough patients (25) to result in statistical significance
- But, every one of the trends indicated decreased of MS with 10,000 to 14,000 U of vitamin D, even though they had Calcium supplements
Derakhshandi et al., 2013;
- Preventive effect of vitamin D3 supplementation on conversion of optic neuritis to clinically definite multiple sclerosis
- “50,000 IU of vitamin D3 weekly for 12 months” to 15 patients
- “Risk reduction was 68.4 % for the primary outcome in the treatment group”
Kampmen et al., 2012;
- Effect of vitamin D 3 supplementation on relapses, disease progression
- “20,000 IU vitamin D(3) weekly” 25 patients
- The 10% risk reduction found after a year was not statistically significant
Kimball etal., 2011; only helped those who got above 40 ng of Vitamin D
- Cholecalciferol plus calcium suppresses abnormal PBMC reactivity in patients with multiple sclerosis.
- “MS-associated, abnormal T cell reactivities were suppressed in vivo by cholecalciferol at serum 25(OH)D concentrations higher than 100 nmol/liter”
Soilu-Hanninen et al., 2012;
- A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon
- Those getting Vitamin D had
1) Decreased burden of disease,
2) fewer new T2 lesions,
3) significantly lower number of T1 enhancing lesions,
4) Tendency to reduced disability accumulation,
5) improved timed tandem walk
Sotirchos et al., 2016;
- Safety and immunologic effects of high-vs low-dose cholecalciferol in multiple sclerosis
- Only 20 Msers, “10,400 IU daily is safe and tolerable . . “
- Vitamin D also improved all MS bio-markers, but only a few were statistically significant for this low of dose and so few participants
Stein et al., 2011
- A randomized trial of high-dose vitamin D2 in relapsing-remitting multiple sclerosis
- 7,000 IU in a study of only 25 patients with a very poor form of Vitamin D
The FDA decided to ignore all meta-analyses of Vitamin D and Multiple Sclerosis
Vitamin D Life believes that “Vitamin D may treat multiple sclerosis” would also be a valid claim
An example study which supports this claim