Headzup: High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache

[xxx]

To all,

This is a dream come true.

https://www.clinicaltrials.gov/ct2/show/NCT04570475?sfpd_s=09%2F16%2F2020&sfpd_d=14 

This is the gold standard RCT protocol I've been working with Dr. Mark Burish, MD, PhD., Will Erwin Headache Research Center, UT Houston School of Medicine to develop for almost a year at this point.   We cut a lot of corners getting the protocol down to two pills with two look alike placebos and no loading dose, but I'm confident this dose will result in at least 70% of CHers responding with a significant reduction in the frequency of their CH during the course of this protocol.

Take care,

V/R, Batch

[FunTimes]

Nice work Batch,

I assume the participants need to stop taking all vitamins prior to the study, How long do you think that would take to clear your system? 

[spiny]

That is great Batch!! This study should provide the proof needed for the Neuros we deal with.  

Wish that I could participate, but the protocol is keeping me cycle free and I can't give that up.

[Pebblesthecorgi]

Congratulations.  This is the sort of stuff that puts wood in a pencil.   Greatly looking forward to see how enrollment goes given the pace of filling spots in the psilocybin study.  I give you all my respect for your hard work.  Your success criteria is a pretty high bar given the accented success of CGRP meds.  Exciting

[Tony Only]

Thank You for all that you do Batch ! 

[kat_92]

Such valuable information! Thank you for all you do Batch. I’m so lucky I found this group

 

kat 

[MickeyP]

Such great news. Many thanks for all your hard work.  I know the Vit D3 regime made a difference for me.

 

[Pebblesthecorgi]

I had a chance to read through the online info at clinical trials.  Any study like this is a lot of work because of the neuro ratio protections and generally inane people who serve on institutional review boards.   As a starting point to collect data regarding safety of Vitamin D and the other factors it will be helpful.  I am a bit skeptical that the time frame is adequate or that the studied will be powered enough to see the predicted outcome.  More importantly because the evolution of the “Batch Protocol” has been ever tweaking what is being studied is certainly a stripped down version which may give a false negative.   These things are so much work and only admiration can be extended to the instigator\/innovator for persistence and dedication.   One last thought.  Because the D3 dosing is fairly high from a conventional perspective it would be beneficial to find some pharmacologist looking to create safety data for high dose  D3 much like has been done for psilocybin.  But that’s another kettle of fish.

[xBoss]

I love it when a plan comes together! TY!

[kate]

Hello all, I started the D3 course two weeks ago. I have seen no improvements to my heavy shadowing. Should I now reduce as have been taking the loading doses? It got so bad that I had to dose with MM which I did twice as usual. Still no relief from shadowing. Any advice welcome, thanks

[xxx]

Hey Kate,

Sorry you're having problems getting started on this regimen.  I've sent you a PM to get the ball rolling to get you back on track for a speedy response to this regimen.

Take care and please keep me posted.

V/R, Batch

[Luis]

Dr. Burish is my neurologist and he told me that you guys were working in something a long time ago. I wish I could help. Unfortunately or fortunately my headaches are controlled by vitamin d so far and I am too much of a scaredy-cat to leave the vitamins. Hopefully everything comes out well in the study. 

[spiny]

Batch, have you put this out on the FB page that so many belong to?

[Gilad102]

On 10/7/2020 at 11:34 AM, kate said:

Hello all, I started the D3 course two weeks ago. I have seen no improvements to my heavy shadowing. Should I now reduce as have been taking the loading doses? It got so bad that I had to dose with MM which I did twice as usual. Still no relief from shadowing. Any advice welcome, thanks

same here Kate,

started the regimen 4 weeks ago. currently on 50,000iu a day along with magnesium 600mg and vitamin k2 mk7, calcium, omega3 and vitamin C.

yesterday was my second bust (1g in lemon tek - was a really strong trip) attempt and still no change, I'm having sever shadows nonstop day and night (kip2-5)  for the last 3 weeks and even more frequent nocturnal episodes that popup every 1-2 hours from falling asleep (with or without melatonin).

the improvement I see for the past weeks is that the pain has reduced to kip 6-7 MAX, most attack stay on kip 4-5  which makes the episodes manageable using Wim Hof breathing technique.

however those shadows are killing me slowly, I have become a shadow of a man because of them. IDK what is the reason I experience it so bad this year, still looking for explanation and hoping everyday for a change to come along with the D3 regimen and MM.

be well, stay strong.

Gilad

[kat_92]

@Gilad102

hey! I get severe shadows during the summer months and along with busting and the vitamin d method they improve a lot. I did need to do quite a few busts to get a pain free status though. I think 5-6 every 5 days. It was tough. Results were worth it though. From what I understand clusters always change up on you once they’re under control  

kat

[Gilad102]

On 10/15/2020 at 5:26 PM, kat_92 said:

@Gilad102

hey! I get severe shadows during the summer months and along with busting and the vitamin d method they improve a lot. I did need to do quite a few busts to get a pain free status though. I think 5-6 every 5 days. It was tough. Results were worth it though. From what I understand clusters always change up on you once they’re under control  

kat

oh dear, 5-6 times until PF that's a lot! but anything is worth being PF:)

do you get on and off the D3 regimen ? I'm planning to keep it on 25,000iu a day after loading period (100,000 FOR  WEEKS 1-3 , 50,000 for weeks4-6)  as I have a friend with CCH who followed that and is pain free for 8 years now after being CCH for 24 years!!

this is a quote from my friends msg regarding the D3 regimen:

week 1 - not much change

week 2 - the clusters are less painful (kip6-7 max)

week 3 - you will feel like it's going to happen but you  will get shadows instead (even for days)

week 4 - -6 the pain stops completely

I will keep trying to bust using the MM, i'm chronic so cannot expect when my next cycle is and it's very hard to bust after it starts..

I hope you get PF soon, waiting for your update..

 

Gilad

 

 

[kat_92]

The great part about the regimen is that you can do it WHILE on MM. so you get the best of both worlds. I stick to 50,000 IU per day for an extra one or two weeks when my cycles are particularly bad 

[Bomachel]

Good Morning Batch

I had a quick question in regards to the D3 regimen. My wife is episodic and we started the D3 regimen a little over a year ago. She is also on monthly emgality. She has had great success with the regimen and emgality combined. She has had a rough time kicking this latest cycle so we increased the vitamin D up to 50,000 IU daily for a little over a month now. She recently went to her doctor after having some dizzy spells. They drew her blood and her results came back with really high Vitamin D levels. (See attached image). Her doctor said to stop taking vitamin D immediately. Our question is how long should we keep her off of the vitamin D and is it ok to start her back on this once her levels are back down? We don’t want to stop this regimen as it has worked great for us. 
 

Thanks

Kevin 

[Pebblesthecorgi]

I'm curious how one defines "great success". 

 

A years worth of Emgality and D3 program but currently in a difficult cycle.  I think about what success means to a cluster head.  Personally I define it to be completely headache free.  So when I get 18 month remission and then have 3-6 months of hell does that mean the busting\D3\CGRP\whatever bought you the remission or was the remission coincidental with the cycle itself?  Sometimes when sucking O2 for the third time a night I wonder if all our solution seeking is just mental masturbation and the cycles will come by whatever path they choose and the busting just helps us cope.  In the heat of a cycle it makes me wonder if anything really works or we are just kidding ourselves.

[xxx]

Hey Gilad,

It's best die episodic CHers to remain on this regimen year-round.  We chronic types don't have a choice.  By staying on this regimen year-round, when your regularly scheduled episodic cycle time comes around, it's likely to be a non-event and you'll skate through the cycle CH pain free.  On top of that, the health benefits of staying on this regimen year-round are hard to ignore like a super boosted immune system high on vitamin D3, helps prevent viral infections like COVID-19.  Even if you do get infected, an immune system boosted on vitamin D3 reduces the severity of viral infections and speeds up recovery time.  There's already a study concluding this benefit for COVID-19.  

You also need to understand that the adult 25(OH)D3 burn rate is roughly 15 ng/mL/month.  That means if you stop taking vitamin D3 while CH pain free with your 25(OH)D3 serum concentration at 80 ng/mL, in as little as three months, your 25(OH)D3 serum concentration will drop down to 35 ng/mL and six to seven months later, it will be even lower so you'll be back as square one with the CH beast jumping real ugly at your next scheduled cycle time. 

The supplements illustrated by brand and dose in the following photo are what I take and suggest to other CHers.  There are two changes to the supplements listed in the posted version of this regimen at the following vitaminDwiki link. 

http://www.vitamindwiki.com/tiki-download_wiki_attachment.php?attId=7708

I made the switch to the Bio-Tech D3-50 50,000 IU water soluble form of vitamin D3 from the liquid softgel vitamin D3 formulations in June of 2018 and the switch to the Methyl Folate + B vitamin complex from the generic vitamin B 50/100 complex in January of 2019 for the following reasons.  We've found the Bio-Tech D3-50 to be faster acting with a higher bioequivalence in elevating serum 25(OH)D3 than the same dose of the liquid softgel vitamin D3 formulations.  The rationale for the switch to the Methyl Folate + was made for the same reason, a higher bioequivalence.

I made another change to the accelerated vitamin D3 loading schedule basically to make it easier and take less time to elevate serum 25(OH)D3 to roughly 80 ng/mL, the initial target.  Instead of the 2-week or 4-week loading schedule, the latest version of the anti-inflammatory regimen calls for a 12-day accelerated vitamin D3 loading schedule taking 50,000 IU/day for 12 days for episodic CHers to reach an initial target of 80 ng/mL, 14 days for chronic CHers to reach an initial target of 90 ng/mL and 16 days for migraineurs to reach an initial target of 100 ng/mL. 

The following graphic illustrates the advantage of these loading schedules over just taking the maintenance dose of 10,000 IU/day.  Data from the online survey of 313 CHers taking this regimen running since December of 2011 indicate the minimum CH threshold in 25(OH)D3 serum concentration above which the CHer is pain free is a range between 40 ng/mL (100 nmol/L) and 50 ng/mL (125 nmol/L).  This survey data also indicates this CH threshold for CHers can be as high as 70 to 90 ng/mL during periods of increased inflammation and immune system activation caused by allergic reactions and infections.

At the end of the applicable loading schedule, if CH pain free, you can drop to an initial vitamin D3 maintenance dose of 50,000 IU once a week and 30 days after starting this regimen, see your PCP/GP for labs of your serum 25(OH)D3, calcium and PTH (Parathyroid Hormone).  The following graphic is 3-year chart of my labs for 25(OH)D3, calcium and PTH.  As you can see, I've kept my 25(OH)D3 serum concentration well above 100 ng/mL and as high as 188 ng/mL the entire time yet my serum calcium has remained within its normal reference range.  My PCP/GP has no problem with my 25(OH)D3 this high as long as my serum calcium remains in the normal range.

If there's been no change in CH patterns after a week to 10 days loading, it's likely you've got something cooking away causing inflammation so it's time to add the supplements illustrated in the following two photos.  Migraineurs will need to add them as well.  You don't need to take them all at once, but I would start by adding the first three supplements illustrated in this first photo.  Our bodies cannot synthesize vitamin C so it's prudent for everyone to take it.  I take 4 to 6 grams/day vitamin C.  The Turmeric (Curcumin) is a potent anti-inflammatory so helps vitamin D3 reduce the neurogenic inflammation associated with CH.   If you suspect an allergic reaction is keeping you from a CH pain free response, I'd start taking 800 mg/day Quercetin.   Among other things, Quercetin is a potent antihistamine and it has no adverse effects like the drowsiness most people get taking Benadryl (Diphenhydramine).  Quercetin is also potent immune booster and broad-spectrum antiviral. 

These three loading schedules are only starting points that should work for most CHers.  There are provisions to continue loading past these schedules under a doctors supervision until you've experienced at least two days (48 hours) CH pain free or 30 days, whichever occurs first.  At that point it's very important to drop back to one D3-50/week and see your PCP/GP for lab tests of your serum 25(OH)D3, calcium and PTH.  

If you've not experienced at least 48 hours CH pain free by the 30 day mark and your serum calcium is still in the normal reference range, work with your PCP/GP for more frequent labs like every ten days then continue loading.  When you ask for labs of your serum 25(OH)D3, calcium and PTH have your PCP/GP specify Quest Diagnostics as they use the Liquid Chromatography, Dual Mass Spectroscopy (LC-MS/MS) assay for 25(OH)D3 that's good to 512 ng/mL.   Some of the other 25(OH)D3 assay methods only go up to 117 ng/mL.

It's important to note that staying on the loading for more than 12 days schedule will elevate serum 25(OH)D3 above 100 ng/mL.  This is not an indication of vitamin D3 intoxication/toxicity.  This is why we need to know the calcium serum concentration.  As long as it remains within its normal reference range, there's no vitamin D3 intoxication/toxicity even if the serum 25(OH)D3 concentration is above 200 ng/mL (500 nmol/L).  We've had some CHers who needed to elevate their 25(OH)D3 above 300 ng/mL under a physician's supervision with frequent labs and their serum calcium concentration remained within its normal reference range.

So there you have it.  All of the information in this post is covered in the draft update to the posted version of this treatment protocol.  I'd hoped to have it ready for prime time last February, but the COVID-19 changed all that as I refocused my efforts on researching the relationship between vitamin D3 and other nutrients with COVID-19.  I'm adding a new section that address taking vitamin D3 and other vitamins and minerals as an immune boosting strategy to prevent and treat COVID-19.

Finally, I'd like to point out that neither my wife or I has had the flu since starting the anti-inflammatory regimen in late 2010.  Neither of us take flu shots or any other Rx medications.  I've also had the RT-PCR assay and tested negative for the SARS-CoV-2 virus three times this summer as a negative on this assay is required within 3 to 5 days of flying to Alaska.

Take care and please keep us posted.

V/R, Batch

[jon019]

@Pebblesthecorgi....interesting question that "success" definition...methinks it's all relative and highly individualistic....

...for decades i never thought that completely PF was realistic....while it happened for some, it seemed so rare that my goal was that which enabled the closest to  a "normal" life......and i do not consider that life and career to have been possible (and therefore successful) w/o O2 and caffeine....

...yet, that was only a ca 80% proposition...leaving 20% to deal with "by any means necessary".  that included D3, all the weird stuff like diet and cayenne powder up the nose, or verapamil and 19 other meds, and triptans (which work great, but i've always thought of as "you can pay me now...or you can PAY me later") so last resort only. may have been fooling myself on occasion, didn't care then, don't care now..."it" worked until it didn't....

...is it all a tail chasin' sonofa girl-squirrel?...YUP!....but perfect is the enemy of the good....livin' between the hits got me through...

best

jonathan

edited to add.....D3 regimen may or may not work for me....the other benefits make it worthwhile.....then, of course, mooshies and such remain a possible if needed....

Edited October 20, 2020 by jon019

[xxx]

Hey Bomachel,

If you've read my last post in this thread to Gilad of a few minutes ago, you would know there's no reason for your wife to stop taking vitamin D3 and that a serum concentration of 150 ng/mL is perfectly safe. I keep my 25(OH)D3 up around 150 ng/mL to remain CH pain free and my PCP has no problem with this.  He knows serum 25(OH)D3 is a poor indication of vitamin D3 intoxication/toxicity even if it's well above 100 ng/mL.

It is a good idea to ask your wife's doctor for lab tests of your wife's serum calcium and PTH (Parathyroid Hormone).  As long as her serum calcium is within its normal reference range, her 25(OH)D3 serum concentration doesn't really matter.  My PCP/GP understands vitamin D3 therapy so has no problems with my serum 25(OH)D3 being well above 100 ng/mL as long as my serum calcium remains within its normal reference range.

As far as emgality is concerned, I'm firmly convinced it's the vitamin D3 that's preventing her CH not the emgality.  I'm not a fan of emgality (galcanezumab-gnlm) or any of the other monoclonal antibodies for the simple reason they weaken the immune system.  Just listen to the TV adds for Humira (adalimumab).  I also think putting foreign DNA in my bloodstream is a very bad idea.  If your wife has a constant craving for cheese and squeaks a lot, the following graphic might just explain why.  It's the murine (mouse) genes...  It's a safe bet your wife's neurologist didn't explain this when he prescribed her emgality.

It's also important to understand that none of the anti-CGRP monoclonal antibodies can ever be fully effective in preventing CH or migraines because they cannot reach the neurons and glia in our trigeminal ganglia where CGRP that causes CH is expressed.  Here's why.  Monoclonal antibodies (mAbs) have a molecular mass of 150 kDa (150,000 Daltons).  The fenestration (windows) through the Blood Brain Barrier (BBB) that protect the brain and CNS from foreign matter has a maximum aperture of 400 Da.  That means these anti-CGRP mAbs are 375 times too big to pass through the BBB.  That emgality has any effect on reducing CH frequency deals with its capacity to lower serum concentration of CGRP expressed by cells outside the CNS.

On the other hand, vitamin D3 and its first metabolite 25(OH)D3 have a molecular mass of 385 Da and 400 Da respectively so both pass readily through the BBB and into the neurons and glia in our trigeminal ganglia where they down-regulate (depress) the expression of CGRP, SP, VIP and PACAP to help prevent our CH.  All of these neuropeptides are elevated during the pain phase of CH and MH.  My degree was in Chemistry if you're wondering.

Take care and please keep us posted.

V/R, Batch

[Bomachel]

Batch

Thank you For the feedback I have attached a copy of an additional test result is this the calcium test that you are referring to?

[xxx]

Bomachel,

The answer to your question is Yuppers, that's exactly the test we need and your calcium serum concentration looks great at 9.8 mg/dL.  This is the assay to watch when loading vitamin D3.  As long as your serum calcium remains within the normal reference range 8.6 - 10.2 mg/dL there is no vitamin D3 intoxication/toxicity and your actual 25(OH)D3 serum concentration doesn't really matter, except as a reference point with respect to your CH activity.

All CHers have a 25(OH)D3 tipping point CH threshold serum concentration, above witch we're CH pain free and at or below this tipping point, the CH beast is jumping ugly.  Moreover, the lower the 25(OH)D3 serum concentration goes below this tipping point threshold, the CH beast ugliness increases, i.e., we get hit harder and more frequently.

There's something else CHers need to understand about staying CH pain free on this regimen and that deals with the relative relationship between our 25(OH)D3 serum concentration and the 25(OH)D3 CH tipping point or threshold serum concentration.  As you can see in the following conceptual graphic, both serum concentrations vary over time, inversely, and this is most frequently due to variations in our immune system activities.  For example, when our immune system activates due to a major source of inflammation caused by an infection, allergic response, trauma or surgery, the CH threshold increases.  At the same time, our 25(OH)D3 serum concentration drops as the white cells that make up most of our immune system increase their affinity for vitamin D3 and its first metabolite 25(OH)D3.  When these two 25(OH)D3 serum concentrations overlap, as illustrated by the purple hashed area in the chart below, the CH beast starts jumping ugly and we get hit.

What CHers taking this regimen also need to understand is keeping your 25(OH)D3 serum concentration high enough to remain CH pain free and avoid these overlaps with attendant CH burn through attacks, will require changes in the vitamin D3 maintenance dose at times.  The 3-year chart of my serum 25(OH)D3, calcium and PTH below illustrates I've done just that.  At times I've taken a vitamin D3 maintenance dose of 25,000 to 30,000 IU/day to avoid the effect of seasonal allergic reactions to pollen and mold spores.  This resulted in my 25(OH)D3 serum concentration elevating as high as 188 ng/mL.  You'll also notice the inverse, mirror relationship between serum calcium and PTH.  This is a classic indication of normal calcium homeostasis, the feedback system our bodies use to maintain serum calcium within a narrow range.

What is significant about this chart is I switched to the Bio-Tech D3-50 50,000 IU water soluble form of vitamin D3 in January of 2019 taking one D3-50/week the day of my labs for 25(OH)D3, calcium and PTH and I've been CH ever since.  As you can also see, this dose has kept my 25(OH)D3 consistently up around 150 ng/mL and my calcium serum concentration has remained in the green zone within its normal reference range.  My PCP/GP has no problem with my 25(OH)D3 this high as he understands the dynamics of vitamin D3 therapy and that as long as the calcium serum concentration remains within its normal reference range and there are no other perturbations in my other labs linked to my 25(OH)D3, both of us are happy.

Hope this helps explain this topic.

Take care and please keep us posted.

V/R, Batch

[Bomachel]

Batch @xxx

Thank you so much for all of the information as it has helped tremendously. I wanted to see what you recommend as my wife keeps getting hit with CHs. We will have 3-5 days of none, and then they will come back at night, usually 2-4 per night. Right now she is taking 40,000 IU of D3 per day will all of the cofactors including some new ones you have added. She takes the vitamins before bedtime. Is there anything we could be doing wrong with this regimen? Please let me know. 

Thanks