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Very disappointing K2 trial

calcification stenosis atherosclerosis menaquinone-7 mk-7

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#1 Richard McGee

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Posted 18 August 2022 - 08:25 PM


Vitamin K2 and D in Patients With Aortic Valve Calcification: A Randomized Double-Blinded Clinical Trial

Originally published25 Apr 2022https://doi.org/10.1...NAHA.121.057008Circulation. 2022;145:1387–1397
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https://www.ahajourn...aortic stenosis.

 

In a randomized, double-blind, multicenter trial, men from the community with an AVC score >300 arbitrary units (AU) on cardiac noncontrast computer tomography were randomized to daily treatment with tablet 720 µg MK-7 plus 25 µg vitamin D or matching placebo for 24 months...The progression in aortic and coronary artery calcification score was not significantly different between patients treated with MK-7 plus vitamin D and patients receiving placebo.

 

A noncontrast cardiac CT scan was obtained at baseline, and repeated after 1 and 2 years of intervention.

 

The progression in aortic and coronary artery calcification score was not significantly different between patients treated with MK-7 plus vitamin D and patients receiving placebo.

 

 


 

This result will be disbelieved or questioned by some in the K2 community, but this trial seems seems very well-designed and executed AFAICT.


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#2 pamojja

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Posted 18 August 2022 - 11:44 PM

..disbelieved or questioned by some in the K2 community

 

I'm in the - "K2-mk7 better combined with plenty K2-mk4, offal for all the others up to mk11, Vitamin D3 including full-body sun-exposure (for nitric oxide, melatonin..) up to at least 60 ng/ml, Retinol and Magnesium to match. Tocotrienols and Mixed Tocopherols, CoQ10 and Astaxanthin... Vitamin C below bowel-tolerance, B-Vitamins - as all nutrients to the max. for improving lab-markers of all body-systems; Pomegranate, Garlic, Blueberry, Green Tea, Goto Kola extracts (to mention a few). Lysine, Betain, AAKG, Citrulline, Taurine, Carnitine, Beta-Alanine.. too many to mention them all. Additional lifestyle and dietary adjustment - again to improve all lab-markers of all body-system" - what-ever-it-takes-Community.

 

Thereby had remission of a 60% walking disabilty from PAD after 7 years, only 3 years took the remission from COPD, and 10 years for remaining ME/CFS symptoms (constant PEMs). 4 years ago.

 

I believe the pharmaceutical model of one agent against an ill (25mcg of Vitamin D is a bad joke) completely insufficient - with natural nutrients who all need each other. As all other diseased body-system have to come on board, for which one has to include lifestyle and dietary changes too.

 

The one man who brought the highest dosed K-Vitamins on the market, and probably took the most K2-Vitamins of us all, even superceeded my other-worldly efforts for remissions, as can be read in detail here: https://www.k-vitami...-view-all&id=18

 

One can't stay a couch potato, have bagels, and believe K2 will miraculously undo all that damage.


Edited by pamojja, 18 August 2022 - 11:51 PM.

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#3 johnhemming

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Posted 19 August 2022 - 06:11 AM

Looking at the methods they used 1000iu vitamin D.  I know that 3,000 vitamin D is insufficient for me to maintain 25OHD levels without a material amount of sun.  I know this from weekly blood tests.  I would carry this forward to other people and conclude 1,000 iu is not enough.

 

However, they should have meaured serum 25OHD levels.

 

K2 can be obtained from diet (natto, cheese) so that also should be measured from serum levels.

 

I agree with the suggestion above that maintaining sufficient of all essential micronutrients is key.

 

Working out what is sufficient  (and not too much) takes quite a bit of reading.


Edited by johnhemming, 19 August 2022 - 06:11 AM.

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#4 pamojja

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Posted 19 August 2022 - 02:23 PM

Working out what is sufficient  (and not too much) takes quite a bit of reading.

 
Even worse, in many cases despite wide reading 'what is sufficient' against disease processes, is simply not known. Or researched with non-patentable molecules. Example:
 
25(OH)D when I started testing 14 years ago had a normal range of 30-100 ng/ml with my labs. About 5 years ago was changed to 30-70 ng/ml. Which is of course due to the gaussian curve, with which 95% of lab results are deemed normal, and the lowest and highest 2.5% abnormal. Easily explainable through the generally decreaed outdoor time and less sun-exposure.
 
Some integrative MDs say at least 40 is optimal, others put it at at least 60ng/ml. We know first toxicity signs (increased serum calcium) can usually be expected only above 180 ng/ml. And we of course simply don't know what consisted normal in past times before the industrial revolution, often with regular offal cunsumption.
 
But by increasing my sun-exposure to the max (since taking the whole web of antioxidants at sufficient doses I never experienced sun-burn without sun-cream anymore), additionally to my regular supplementation (in average 8800 IU7D, to keep me in average at 70 ng/ml the last 14 years) I accidentally shoot up to 135 ng/ml. And what a coincidence that exactly then my most delayed remission of my 3 chronic diseases occured. Maybe dispite? - we simply can't know.
 

K2 can be obtained from diet (natto, cheese) so that also should be measured from serum levels.

 

One available lab method in research settings to meassure K2 status, was actually used in above Study. However, for example with an other: undercarboxylated Osteocalcin, the sky is the limit for vitamin K2 intake, and still lowering it further (as Patrick form k-oncentrated Ks has found).


Edited by pamojja, 19 August 2022 - 02:33 PM.

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#5 Richard McGee

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Posted 19 August 2022 - 04:41 PM

Lets parse out what this study is actually saying. 720 µg MK-7 was administered daily over a 24 month period. This is not an insignificant dose, nor was the trial length too short to draw conclusions. 

 

At the end of 12 and 24 months, there was no CT calcium score difference between the K2 group and the control group. (Remember calcium scoring is the most accurate objective test for determining the actual level of arterial blockage.)

 

So what does this tell us?

 

It doesn't say K2 is not significant in a good diet, nor does it say that other cofactors are not also significant. What it DOES suggest is that high dose K2 is not an effective tool for regressing or stabilizing arterial plaque.

 

Certainly I will continue with K2 in my diet via food intake and supplementation. However I'm putting the Koncentrated K level of supplementation on hold in my personal regimen.

 


Edited by Richard McGee, 19 August 2022 - 04:42 PM.

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#6 Mind

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Posted 19 August 2022 - 05:28 PM

Thanks for posting this interesting data. It does look like a pretty well-designed study. If I am reading the headline numbers correctly, it looks like the AVC scores were slightly better among the treatment group (225-326 vs 246-338), but it did not reach statistical significance. There was substantial overlap in the scores of the two groups.


Edited by Mind, 19 August 2022 - 05:29 PM.

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#7 pamojja

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Posted 19 August 2022 - 06:03 PM

So what does this tell us?

 

The pharmaceutical model, one agent at time, without conutrients and supporting lifestyle changes will never work in complex disease processes. Especially so at advanced as in ~71 years olds.

 

It doesn't say K2 is not significant in a good diet, nor does it say that other cofactors are not also significant. What it DOES suggest is that high dose K2 is not an effective tool for regressing or stabilizing arterial plaque.

 

Certainly I will continue with K2 in my diet via food intake and supplementation. However I'm putting the Koncentrated K level of supplementation on hold in my personal regimen.

 

To be precise, high dose K2-mk7 alone.

 

Koncentrated K levels wasn't even closely tested, with its additonal K1+K2-mk4 content of 30 mgs.

 

But I agree, without already present disease process in calcification, no need to take such therapeutic amounts (with all cofactors alike in therapeutic doses).


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#8 Mind

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Posted 19 August 2022 - 06:13 PM

I should also highlight the fact the the inventor of Koncentrated K did reverse his arterial plaque and advanced heart disease. I have met him. His story is legit. He is quite healthy for his age.

 

However,

 

His approach to reversing heart disease was very comprehensive. He changed a lot. He was unhealthy, overweight, and sedentary. When he was told he did not have long to live because of his heart disease, he started exercising, a keto diet, and multiple new supplements, etc... He reasons that vitamin K was a key part of his success. This study would say maybe it is only a minor part.


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#9 pamojja

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Posted 19 August 2022 - 07:41 PM

This study would say maybe it is only a minor part.

 
As someone with triple remissions and also on a comprehensive approach for years I can tell without doubt, that every nutrient involved taken alone could never accomplish the same. Would not only be a minor, but surely insufficent part.
 
Otherwise there would be masses shouting about remissions from chronic disease considered incureable by the standart medicine approach, all taking only one or the other.

 

But alas, they are very rare. All of them on a comprehensive approach including nutrition, life-style changes and supplements.


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#10 ironfistx

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Posted 28 August 2022 - 05:44 PM

My replies.

The person who said hypercalcemia only happens at high D amounts is wrong. I have had it twice and both times my quantities were under 45.

And 720 micrograms of K2? Isn't that a big dose?

I misread and figured my tablets were 100mg. They are mcg. So. What they used was nearly 7 times as much.

Edited by ironfistx, 28 August 2022 - 06:38 PM.


#11 ironfistx

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Posted 06 September 2022 - 09:15 PM

I'm in the - "K2-mk7 better combined with plenty K2-mk4, offal for all the others up to mk11, Vitamin D3 including full-body sun-exposure (for nitric oxide, melatonin..) up to at least 60 ng/ml, Retinol and Magnesium to match. Tocotrienols and Mixed Tocopherols, CoQ10 and Astaxanthin... Vitamin C below bowel-tolerance, B-Vitamins - as all nutrients to the max. for improving lab-markers of all body-systems; Pomegranate, Garlic, Blueberry, Green Tea, Goto Kola extracts (to mention a few). Lysine, Betain, AAKG, Citrulline, Taurine, Carnitine, Beta-Alanine.. too many to mention them all. Additional lifestyle and dietary adjustment - again to improve all lab-markers of all body-system" - what-ever-it-takes-Community.

 

Thereby had remission of a 60% walking disabilty from PAD after 7 years, only 3 years took the remission from COPD, and 10 years for remaining ME/CFS symptoms (constant PEMs). 4 years ago.

 

I believe the pharmaceutical model of one agent against an ill (25mcg of Vitamin D is a bad joke) completely insufficient - with natural nutrients who all need each other. As all other diseased body-system have to come on board, for which one has to include lifestyle and dietary changes too.

 

The one man who brought the highest dosed K-Vitamins on the market, and probably took the most K2-Vitamins of us all, even superceeded my other-worldly efforts for remissions, as can be read in detail here: https://www.k-vitami...-view-all&id=18

 

One can't stay a couch potato, have bagels, and believe K2 will miraculously undo all that damage.

 

This guy recommends taking 4 150 B capsules per day.  Oof.

 

In his document, he says this:

 

starting point about 4 Multi-B’s per day, known as “B-150’s”.

 

This isn't isn't to reject his views, I'm just saying, that's a large dose.

 

That would be 600mg of B6 per day.


Edited by ironfistx, 06 September 2022 - 09:15 PM.

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#12 pamojja

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Posted 06 September 2022 - 11:50 PM

This guy recommends taking 4 150 B capsules per day.  Oof.

 

 

This isn't isn't to reject his views, I'm just saying, that's a large dose.

 

That would be 600mg of B6 per day.

 

He probaly only says what he is taking, or can you link to a general recommendation?

 

The reason he take lots of B Vitamins is, because they're eaten for breakfast by alcolhol, which he uses beside other things to raise his HDL. Even half glass of wine and my liver-enzyms would be screaming - no amount of Bs till now would rectify. So I and many can do with much less.

 

However, it has to be P-5-P for me, Pyridoxine much above 100mg and I do get reversible neuropathy. A side-effect never had with Pyrodoxal-5-Phosphate form. I know of others who get neuropathy with any amount of Pyridoxin, so how much B6 is too much is very individual.

 

 

Edit: here is the quote not taken out of context:

 

 

Tip on HDL:  eating fats increase your HDL and to a lesser extent and be careful with this is ingestion of alcohol.  The HDL bump from alcohol is on a U-shaped curve so a rule of thumb is a couple of “shots” is ok per day as long as you have sufficient “B” vitamins.  Try to get your HDL level to match your D level.  So, how much “B” vitamins to take?  Assuming you don’t have a Folate metabolism issue, like the author, it is suggested as a good starting point about 4 Multi-B’s per day, known as “B-150’s”.

 

Many year ago he used Puritans Pride, which would be this today: https://www.puritan....-complex-003802 , with only 100mg Pyridoxine per capsule, or 400mg per day.

 


Edited by pamojja, 07 September 2022 - 12:04 AM.


#13 pamojja

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Posted 07 September 2022 - 12:13 AM

My only recommendation would be to start with any nutrient in its lowest possible dose, if needed by taking only a fraction of a capsule, and increase gradually over weeks, months and years. While monitoring symptoms and lab-work.

 

That being said, I used in average the following amounts of the Bs for 14 years, always further adapting:

 

530 mg B1

170 mg B2

3160 mg B3

400 mg B4 Choline

1970 mg B5

170 mg B6

5,4 mg B7

6700 mg B8 Inositol

2.1mg B9

410 mg B10 PABA

2 mg B12

 

Just as example, what it could mean to take whatever it takes, with multple metabolic shortcomings and chronic diseases.

 

One reason one has to be careful with increasing doses of individual B Vitamins is, that they interweave with each others cycles. So if only one is taken at individually high doses, it might increase the need of some other B-Vitamins not taken sufficiently, and thereby falling deficent for its now increased use.

 

B_metabolism.gif
 
Therefore increase new nutrients always slowly along with co-factor nutrients. And adjust always.

Edited by pamojja, 07 September 2022 - 12:39 AM.


#14 johnhemming

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Posted 07 September 2022 - 04:50 AM

However, it has to be P-5-P for me, Pyridoxine much above 100mg and I do get reversible neuropathy. A side-effect never had with Pyrodoxal-5-Phosphate form. I know of others who get neuropathy with any amount of Pyridoxin, so how much B6 is too much is very individual.

 

 

I have come to exactly the same conclusion for the same reason.  Pyridoxine inhibits P5P.



#15 ironfistx

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Posted 12 September 2022 - 08:51 PM

I have posted this thread on raypeatforum.com to generate more dicussion.  https://raypeatforum...k2-study.47729/



#16 Gal220

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Posted 14 September 2022 - 06:18 AM

Was the tablet the right form of MK-7?

https://www.vitafood...-key-doesnt-fit

 

"When producing vitamin K2, production and stability issues make it extremely difficult to create an all-trans molecule and result in some or all chemical bonds presenting the cis form, mostly considered biologically inactive."

 

Only a few supplements specify cis vs trans form, I'm not aware of this issue with MK-4 which is far more common



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#17 ironfistx

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Posted 18 September 2022 - 09:44 PM

Good point, you posted.

Edited by ironfistx, 18 September 2022 - 09:49 PM.






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