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Double blinded, randomized and controlled trial including 80 patients will start sometime soon in Germany.
It will be interesting to hear the result in a little more than 18 months.

High dose group on 10.200 IU/day vs. low dose group on 200 IU/day.

Unfortunately, all patients are required to be on interferon-beta1b during the study.
"the work was supported ... by a limited research grant by Bayer Vital GmbH, Germany"

I find the arguments for doing the trial with interferon a little vague.

But then again, if noone else are willing to support theese trials I guess its far better than nothing.

Having all the participants on the same MS treatment does remove the potential for varying responses with other medications, and ensures that no-one is missing out on currently accepted, effective treatment.


OMG December 2011 OMS January 2012 OMS Retreat March 2012 Benign MS Sep 2015
Two Very Mild Relapses since diagnosis. Copaxone May 2013 No new lesions on MRI since diagnosis

However, this concern seems to be of less importance in other studies where drugs – as far as I know – often a trialled against placebo as opposed to e.g. interferon. At the same time I believe that patients respond very differently to interferon.

But in two years, I guess, we will still be left with the question if any positive effect really came from high dose vitamin D or vitamin D in combination with interferon. As it’s stated in the article “Importantly, a recent EAE study provided evidence for a synergistic effect of a vitamin D analogue and interferon-β”.

I would, without having any knowledge whatsoever on design of theese studies, find it more logical to start out with a controlled and blinded study of high dose vitamin D on its own before testing it in combination with other treatment options. As far as I know such a study has never been done.
They might have difficulty recruiting patients for a placebo-controlled trial. I know I've refused to participate in trials for that reason ("what, and there's a 50-50 chance I get NO TREATMENT AT ALL!? Erm, no thanks..."). Also they might consider it unethical to use placebo as the control when there are current standard treatments for MS - when there's an existing widely-used treatment for an illness, we're no longer as interested in "is this treatment better than a sugar pill?" and more interested in "is this treatment better than the current standard?", and there are obvious concerns about the welfare of patients in the placebo group.

Research goes in steps - they take the easiest, most achievable steps first, and then if the results are good, that supplies the argument for taking the next step. It can be frustratingly slow, but clinical trials are extremely expensive (large, controlled, randomised, double-blinded trials most expensive of all) so there has to be a very persuasive argument to convince the funding body that it's worthwhile (whether it's charities looking for health benefits, governments looking for a reduction in the costs of health and social care, or pharma companies looking for a marketable product). Maybe the results of this trial will convince a government body to fund a trial purely focused on vitamin D?
I also read this article from MSRA this week but still not sure of the dosage sizes they are using but i would assume they will be high.

Vitamin D could be weapon against MS

Updated: 05:59, Wednesday February 22, 2012

A clinical trial will test whether Vitamin D can help fight multiple sclerosis (MS).

If successful, researchers say the trial could open the door to a treatment which is 100 times cheaper than other drugs available.

The $2 million trial, announced on Wednesday by MS Research Australia, will begin recruiting in Victoria, NSW, Tasmania and New Zealand from April.

Researchers hope to find 150 people with early or suspected symptoms of MS and put them on varying doses of Vitamin D.

'If we can ... watch to see if that actually slows the progress or stops the progress, and they don't actually get MS, then we know Vitamin D is having an effect,' MS Research Australia CEO Jeremy Wright told AAP.

The vitamin, which can be sourced from sunlight and some foods, is gaining credence as an effective treatment in preventing MS.

But all the evidence so far has been circumstantial, Mr Wright said.

'If we can prove the efficacy we are going to come up with a treatment which, would you believe, is about 100 times cheaper than the current treatments,' Mr Wright said.

'But it won't be a solo treatment. It will join the other treatments and add impacts, is what we expect.'

He said it was hoped the study would show some results in five years.

Some 20,000 Australians are diagnosed with MS, an incurable disease which attacks the central nervous system and can cause bladder dysfunction, spasticity, depression and cognitive problems

http://www.skynews.com.au/health/articl ... 21026&vId=
There will be four arms to the trial: placebo, 1000 IU, 5000 IU and 10,000 IU of D3.
I wouldn't like to be one of the participants on placebo!

Also, I think diet will be another variable to affect the results.




OMG December 2011 OMS January 2012 OMS Retreat March 2012 Benign MS Sep 2015
Two Very Mild Relapses since diagnosis. Copaxone May 2013 No new lesions on MRI since diagnosis
For sure.
And if more result in the coming periode indicate a benefit in high dose (e.g. 10.000IU) vs. low dose (e.g. 1000IU) - or vice versa for that matter - how will that effect drop out in this 4 year trial?!
At least that is one advantage in a trial where interferon is combined with vit d - more motivation to stay in the study for those who do not have access to free drugs.
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