Multiple Sclerosis is again not fought by 5,000 IU vitamin D daily (need at least 10X more) – RCT May 2023

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High-dose vitamin D3 supplementation in relapsing-remitting multiple sclerosis: a randomised clinical trial

EClinicalMedicine. 2023 Apr 13;59:101957. doi: 10.1016/j.eclinm.2023.101957
Sandra D Cassard 1, Kathryn C Fitzgerald 1, Peiqing Qian 2, Susan A Emrich 1, Christina J Azevedo 3, Andrew D Goodman 4, Elizabeth A Sugar 5, Daniel Pelletier 3, Emmanuelle Waubant 6, Ellen M Mowry 1

About 1/2 year for the Vitamin D response to plateau

Background: Vitamin D insufficiency is associated with risk of multiple sclerosis (MS) relapse; whether supplementation influences prognosis is unknown. The Vitamin D to Ameliorate MS (VIDAMS) trial aimed to determine if high dose (5000 International Units (IU)/day) versus low dose (600 IU/day) vitamin D3, added to daily glatiramer acetate (GA), reduced the risk of clinical relapse in people with established relapsing-remitting MS (RRMS) over 96 weeks.

Methods: VIDAMS is a randomised, phase 3, double-blind, multi-centre, controlled trial conducted at sixteen neurology clinics in the United States. Participants with MAGNIMS 2010 RRMS, aged 18-50 years, with recent disease activity were eligible to enroll if they had an Expanded Disability Status Scale score ≤4.0; minimum serum 25-hydroxyvitamin D level of 15 ng/ml within 30 days of screening; and average ≤ 1000 IU supplemental vitamin D3 daily in the 90 days prior to screening. Of 203 screened, 183 were eligible for the 30-day run-in to assess GA adherence, after which 172 were randomised 1:1 to low dose vitamin D3 (LDVD) or high dose vitamin D3 (HDVD), and were followed every 12 weeks for 96 weeks. The primary outcome was the proportion that experienced a confirmed relapse and analyses used Kaplan Meier and Cox proportional hazards models. 165 participants returned for ≥1 follow-up visit and were included in the primary and safety analyses; 140 completed a week 96 visit. This study was registered with ClinicalTrials.gov, NCT01490502.

Findings: Between March 22, 2012 and March 8, 2019, 172 participants were enrolled and randomised (83 LDVD, 89 HDVD) and differed at baseline only in gender and race: more males received HDVD (31%) than LDVD (16%), and fewer Black participants received HDVD (12%) than LDVD (22%). Among 165 participants with at least one follow-up visit, the proportion experiencing confirmed relapse did not differ between LDVD and HDVD [at 96 weeks: 32% vs. 34%, p = 0.60; hazard ratio (HR): 1.17 (0.67, 2.05), p = 0.57]. There was no hypercalcaemia. Three participants developed nephrolithiasis or ureterolithiasis (1 in the LDVD and 2 in the HDVD group). Two were possibly related to study drug; and one was presumed related to concomitant treatment with topiramate for migraine.

Interpretation: VIDAMS provides evidence that HDVD supplementation, added to GA, does not reduce the risk of clinical relapse in people with RRMS. Taken together with the null findings of previous trials, these results suggest that prescribing higher doses of vitamin D for purposes of modifying the RRMS course may not be beneficial.

Funding: This investigation was supported by a grant from the National Multiple Sclerosis Society (RG 4407A2/1). Teva Neuroscience, Inc. provided Copaxone (GA) for the duration of the trial.
 Download the PDF from VitaminDWiki

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VitaminDWiki - 12 studies in both categories Multiple Sclerosis and VitaminD Receptor

This list is automatically updated

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VitaminDWiki - 2 studies in both categories Multiple Sclerosis and Magnesium

This list is automatically updated

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VitaminDWiki – Overview MS and vitamin D contains

Clinical interventions have shown that Vitamin D can prevent, treat, and even cure Multiple Sclerosis, at a tiny fraction of the cost of the drugs now used to treat it, and without side effects.

• Fact: Low Vitamin D results in higher risk of getting MS
  Increase latitude leads to decreased Vitamin D, which leads to increased risk of MS
  
  
  There is less of an effect recently - air conditioning now allows people to stay indoors

  
  
  Dark skinned people are far more likely to get MS (dark skin people typically have low vitamin D)
  Elderly (who typically have low vitamin D) are more likely to get MS
  Is there increased risk in people who already have diseases associated with low vitamin D - TB, for example ? ? ?
  Women typically have 3X increased MS risk then men (note: women typically have 20% lower levels of vitamin D than men)
     Exception: women in very sunny climates and dark-skinned women have the same MS risk as men
  Obese are 60% more likely to get MS
  Multiple Sclerosis 42X more likely if light brown skin and smoke (both associated with low vitamin D) – July 2020
  MS recurrence is much higher in spring - the lowest time of the year for vitamin D
  increase in clouds/rainfall (which reduces available Vitamin D) is associated with increased risk of MS (Scotland, Western Washington)
  MS incidence has increased 70% in a decade while the incidence of vitamin D deficiency doubled
  Less MS in those with outdoor occupations PDF file, not a web page
• Fact: MS uses up Vitamin D
• Fact: Lower vitamin D (due to MS using up Vitamin D while fighting the disease) results in many other health problems (such as broken bones), so depleted vitamin D levels must be restored.
  
  Fact: Increasing levels of Vitamin D is associated with lower MS risk, as well as lower risk of many other diseases

  
• Fact: Vitamin D looks so promising for preventing and treating MS that there were 25 INTERVENTION clinical trials as of Feb 2014
• Fact: Vitamin D reduced the MS relapse rate far better than Fingolimod which is now used for that purpose.
  • Note: Fingolimod costs $25,000/year while vitamin D, which works better and has no side effects is 1000 times less expensive.
• Fact: 98% of the genes affected by Interferon are also affected by Vitamin D
  • Note: 1 week of Interferon = $4,700, 1 week of vitamin D 10,000X lower cost
• Fact: MS Doctors in Brazil recommending 40-100 ng/mL of Vitamin D
• Fact: Many MS forums are recommending vitamin D to treat MS, with some taking 5,000 to 10,000 IU daily
  Observation: Risk of going from pre-MS to MS reduced 68 percent with 7100 IU vitamin D – RCT Dec 2012
  • This is an observation instead of a fact - it has not yet been confirmed.
• Fact: VERY LARGE doses of vitamin D have CURED 2,000 people of MS in Brazil
• Controversy: UVB fron sunlight or UVB bulb may be BETTER than Vitamin D for reducing the risk of getting MS
• Hypothesis: In addition to Vitamin D there are many other photoproducts produced by UVB that may promote health.

Summary: lack of consensus on how much to prevent, treat, or cure MS.

• How much Vitamin D to prevent many diseases - such as MS
• How much Vitamin D is needed to treat MS? There is currently no agreement
     The recommendations range from 40 to 100 ng - which can result of a dose ranging from 3,000 to 20,000 IU/day
• How Vitamin D is needed to Cure MS?: It appears that 20,000-140,000 IU daily may be needed to CURE the disease
     You must be under the supervision of a doctor who knows what to watch for in your individual situation.
     High doses of Vitamin D cannot be used as a monotherapy.
     You will need to adjust the cofactors: Typically increasing Magnesium and Vitamin K2, and reducing Calcium intake.
     Your doctor will monitor these and might increase your intake of Vitamins B2, C, as well as Omega-3899
• Epstein-Barr virus increases risk of Multiple Sclerosis by 32X - Jan 2022
• Multiple Sclerosis treated by Vitamin D, recommends investigating high dose Coimbra - Oct 2021
• Multiple Sclerosis patients had fewer COVID-19 problems (Note: many MSers take Vitamin D) – April 30, 2021
• Vitamin D Resistance hypothesis confirmed by Coimbra high-dose vitamin D protocol – April 2021
• Multiple Sclerosis relapses cut in half by 100,000 IU of Vitamin D every 2 weeks– RCT 2019

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VitaminDwiki – Better than Daily contains

31 items in BETTER THAN DAILY category

Non-daily (Bolus) is better:

1. Better compliance for everyone
   • Fewer opportunities to forget.
   • If happen to forget, just take the pill days or weeks later
   • Fewer times to have to take a pill - for those who dislike doing so
2. Non-daily is better the ~20% who have a poor Vitamin D Receptor
   • A high concentration gradient is one of 14 ways to get past Vitamin D Receptor limitations
   • So, while 80% get no extra benefit from non-daily dosing, 20% will get an extra benefit

• Vitamin D given daily, weekly, or monthly has similar response (116 RCTs) – meta-analysis Aug 2023
• 44 percent of successful RCTs in VitaminDWiki used non-daily dosing - Nov 2020
• Monthly vitamin D dosing better for children than daily (again) - Oct 2023

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40-150 ng of Vitamin D is needed to treat many health problems

Vitamin D	Treats
150 ng	Multiple Sclerosis *
80 ng	Cluster Headache * Reduced office visits by 4X *
70 ng	Sleep *
60 ng	Breast Cancer death reduced 60% Preeclampsia RCT
50 ng	COVID-19 Fertility Psoriasis Infections Review Infection after surgery
40 ng	Breast Cancer 65% lower risk Depression ACL recovery Hypertension Asthma?
30 ng	Rickets

* Evolution of experiments with patients, often also need co-factors