Vitamin D - Clinical Trials

A forum to discuss the Coimbra Protocol which uses high-dose vitamin D3 to treat multiple sclerosis.
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AntonioBR
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Vitamin D - Clinical Trials

Post by AntonioBR » Wed Feb 10, 2016 8:06 am

Vitamin D and MS - Clinical Trials
Last edited by AntonioBR on Wed Feb 10, 2016 8:15 am, edited 1 time in total.

AntonioBR
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Re: Vitamin D - Clinical Trials

Post by AntonioBR » Wed Feb 10, 2016 8:12 am

Jan-Markus Dörr, Charite University, Berlin, Germany
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Dose: 20 000 IU/2d 400/2d of vitamin D3 versus 400/2d, for 18 months
Estimated Enrollment: 80
Start Date: December 2011
Completion Date: December 2016
NCT Number: NCT01440062

Brief summary:
Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

Publication(s):
Dörr J, Ohlraun S, Skarabis H, Paul F. Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial. Trials. 2012 Feb 8;13:15. doi: 10.1186/1745-6215-13-15.


Source: http://www.clinicaltrials.gov/ct2/show/ ... CT01440062

AntonioBR
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Re: Vitamin D - Clinical Trials

Post by AntonioBR » Wed Feb 10, 2016 8:14 am

Preventing the risk of Multiple Sclerosis using Vitamin D in patients with a first demyelinating event in Australia and New Zealand (PrevANZ)

Dose: Vitamin D3 1 000 IU/d, 5 000 IU/d, 10 000 IU/d or placebo, for 48 weeks
Estimated Enrollment: 240
Start Date: December 2012
Completion Date: 2017
ACTRN 12612001160820

Brief summary:
Phase IIb Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Trial to determine the safety and efficacy of Vitamin D3 in preventing the risk of MS in Patients with a first demyelinating event.

Source: https://www.anzctr.org.au/Trial/Registr ... 2001160820

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CureOrBust
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Re: Vitamin D - Clinical Trials

Post by CureOrBust » Wed Feb 10, 2016 6:35 pm

The above quoted trials are NOT "Coimbra Protocol" and cannot be used as evidence for such. Coimbra protocol is a dose of the order of say 60000IU+ whereas the first study is 10000IU and the second is only 1000IU to a max of 10000IU. The step up to 6+ times the dose could be very significant. Simply look at the dose escalation for Gylenya. They found the slightly higher dose was actually LESS effective than the lower (and now recommended) dose. More is not always better.

With the huge differences in magnitude of doses between these studies and the Coimbra Protocol I think it i unjustified to use the above studies in anyway as justification for the doses used in Coimbra and therefore both the above posts are actually "off-Topic" in this thread and would be more appropriately posted in the General Forum.

Also, the second study is regarding the effects between the first demylinating event and the development of MS. Not the ongoing treatment of MS which is also very different to the Coimbra protocol.

I checked the second study, and no results have been published, so no conclusions/assumptions should be drawn or implied that the treatment was beneficial simply because the study is proposed. ie lets discuss the results not the proposal.

http://www.thisisms.com/forum/coimbra-h ... 27182.html
AntonioBR wrote:-The Standard Dose
Dr. Coimbra and Dr. Michael Holick found that 1,000 IU of Vitamin D3 per kilogram (or 500 IU per pound) is a good standard dose for people with autoimmune disease. They should take it every day. And if the person is obese "maybe" he/she should take more Vitamin D3. Because fat cells can steal vitamin D from your bloodstream. Dr. Michael Holick has a study and an interview about it.
The initial dose they recommend is: 1,000 IU D3/Kg. So, if a person weight 100kg (220.46 pounds) he/she should take 100,000IU Vit. D3 per day.
AntonioBR wrote:Jan-Markus Dörr, Charite University, Berlin, Germany
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Dose: 20 000 IU/2d 400/2d of vitamin D3 versus 400/2d, for 18 months
Which is 10000iu/day
AntonioBR wrote:Preventing the risk of Multiple Sclerosis using Vitamin D in patients with a first demyelinating event in Australia and New Zealand (PrevANZ)

Dose: Vitamin D3 1 000 IU/d, 5 000 IU/d, 10 000 IU/d or placebo, for 48 weeks
A paper regarding the trial (does not contain the actual results) also states
Another important question relates to the dose used in the high-dose arm. In fact, we do not know, at which minimum doses or serum levels vitamin D starts to have immunomodulatory effects. To prevent failure of the trial because of an insufficient treatment dose, we choose the maximum dose for which sufficient safety data are available, which currently corresponds to 10.000 IU per day [23]. It might well be that already smaller doses would be sufficient, but on the other hand it is rather unlikely, that if this dose does not demonstrate any treatment effect, even higher daily doses would do
The implication of the last sentence quoted above is that the researchers think a lower dose (than 10000IU) may be sufficient and that a higher dose would not help if the 10000IU does not help...document link here...

Anyone on the Coimbra Protocol may also wish to read their cited article at 23; I have not read it.

RufusG
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Re: Vitamin D - Clinical Trials

Post by RufusG » Thu Feb 11, 2016 12:14 am

High strength Vitamin D is available
Free delivery to UK and all the countries of Europe
Search for "GreenVits"

AntonioBR
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Re: Vitamin D - Clinical Trials

Post by AntonioBR » Thu Feb 11, 2016 6:43 pm

Hi Cure,

About your post:
Coimbra protocol is a dose of the order of say 60000IU+ whereas the first study is 10000IU and the second is only 1000IU to a max of 10000IU. The step up to 6+ times the dose could be very significant.
I agree with you more is not always better. Coimbra's Protocol doesn't have a dose of 60,000IU/D3 or higher. In fact, there are people that take half of this dose.

They use the levels of Parathormone to measure the patient's resistance to Vitamin D. Second Coimbra's theory people with autoimmune diseases has a genetic polymorphism. Hence, they should take a higher dose of D3.

If some patient has a low resistance to Vit. D then his dose will also be low.

For example, My aunt has arthritis rheumatoid and she takes only 20,000 IU D3/day following Coimbra's Protocol. There are people with MS for more than 12 years that take only 30,000IU D3.

The above quoted trials are NOT "Coimbra Protocol" and cannot be used as evidence for such.
On this thread, I want to post all the clinical trials related to Vitamin D and MS. Even if goes against Coimbra's Protocol. I'm not aiming at defending this protocol at every cost. If possible, I want to discover the best treatment to MS

Unfortunately, as you already know Coimbra didn't publish a specific study of this protocol for MS patients. And it's a big flaw. Maybe now with the help of Dr. Michael Holick - that has a huge experience in publishing scientific data - we can expect some improvement.

He published only a study for vitiligo and psoriasis. Using the same argument for MS and others autoimmune diseases.

http://www.ncbi.nlm.nih.gov/pubmed/?ter ... A+24494059

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897595/

However, we can't reject the experince of almost +12,000 people following this treatment. They are getting much better than the conventional treatment. Some had an enormous improvement.
(Although, a scientific study is necessary.)

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CureOrBust
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Re: Vitamin D - Clinical Trials

Post by CureOrBust » Thu Feb 11, 2016 11:08 pm

AntonioBR wrote:On this thread, I want to post all the clinical trials related to Vitamin D and MS. Even if goes against Coimbra's Protocol. I'm not aiming at defending this protocol at every cost.
Without results these are nothing. However, by posting these without results will have people assume the outcomes were positive, which is misleading. Is that what you want?
If possible, I want to discover the best treatment to MS
If this statement is truly the case, what other treatments have you investigated? And what criteria do you use to validate their true effectiveness?

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Re: Vitamin D - Clinical Trials

Post by AntonioBR » Fri Feb 12, 2016 5:03 am

CureOrBust wrote:Without results these are nothing. However, by posting these without results will have people assume the outcomes were positive, which is misleading. Is that what you want?
Scientific studies are a 'must'. But think that +12,000 people are misleading themselves it's very unlikely. Overall, the average placebo effect is 33%.

Coimbra is gathering all the patient's data and he is sending it to Dr. Michael Holick in US.

I hope that soon we will have a scientific study - more detailed - about this protocol effectiveness.

If this statement is truly the case, what other treatments have you investigated? And what criteria do you use to validate their true effectiveness?
I'm reading about LDN and Biotin.

My first criteria are scientific studies - especially systematic reviews and meta-analysis.

However, as far as I know we don't have systematic reviews and meta-analysis for numerous treatments: Dr. Whelton Antibiotics, Natural Approach, George Jelinek's diet, Whal's Diet, LDN, Coimbra's Protocol, etc.

Moreover, like said Dr. Terry Whals on her book The Wahls Protocol: A Radical New Way to Treat All Chronic Autoimmune Conditions Using Paleo Principles and on her website:
Conducting research is an expensive endeavor. Seed funds to help collect a small amount of pilot data, like Dr. Wahls’ current study, range from $75,000 to $100,000. A somewhat larger study testing the safety and tolerability of a study will cost $250,000 to $500,000. A clinical trial that is large enough to prove that the intervention is effective often costs a million dollars or more. Dr. Wahls has sent multiple grant proposals for $450,000 to the National MS Society and the National Institutes of Health (NIH), but has thus far has not been funded.
So, there is a financial problem related.

Hence, a scientific study can take years to be funded and more years to be completed.

I'm open to listening to people's experience especially when thousands had the same improvements.
Last edited by AntonioBR on Sun Feb 14, 2016 12:21 pm, edited 3 times in total.

scsi
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Re: Vitamin D - Clinical Trials

Post by scsi » Fri Feb 12, 2016 5:39 am

AntonioBR wrote:But think that +12,000 people are misleading themselves it's very unlikely
Without actual results, you will never know.

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Re: Vitamin D - Clinical Trials

Post by Petr75 » Thu Feb 20, 2020 12:02 pm

2020 Jan 24
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Germany
High-dose Vitamin D Supplementation in Multiple Sclerosis - Results From the Randomized EVIDIMS (Efficacy of Vitamin D Supplementation in Multiple Sclerosis) Trial
https://pubmed.ncbi.nlm.nih.gov/3204764 ... sis-trial/

Abstract

Background: Epidemiological, preclinical, and non-interventional studies link vitamin D (VD) serum levels and disease activity in multiple sclerosis (MS). It is unclear whether high-dose VD supplementation can be used as an intervention to reduce disease activity.

Objectives: The study aimed to compare the effects of every other day high- (20,400 IU) versus low-dose (400 IU) cholecalciferol supplementation on clinical and imaging markers of disease activity in patients with relapsing-remitting MS or clinically isolated syndrome.

Methods: The EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial was a multicentre randomized/stratified actively controlled explorative phase 2a pilot trial with a double-blind intervention period of 18 months, add on to interferon-β1b.

Results: Fifty-three patients were randomized, and 41 patients completed the study. Cholecalciferol supplementation was well tolerated and safe in both arms. After 18 months, clinical (relapse rates, disability progression) and radiographical (T2-weighted lesion development, contrast-enhancing lesion development, brain atrophy) did not differ between both treatment arms. Post-study power calculations suggested that the sample size was too low to prove the hypothesis.

Conclusions: The results neither support nor disprove a therapeutic benefit of high-dose VD supplementation but provide a basis for sound sample size estimations in future confirmatory studies. www.clinicaltrials.gov/NCT01440062.

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