Brew's comments on vitamin D3 dosing, 25(OH)D serum concentrations and vitamin D3 toxicity are spot on!

A recent study titled Vitamin D Supplement Doses and Serum 25-Hydroxyvitamin
D in the Range Associated with Cancer Prevention by Garland, French, Baggerly and Heayey concluded that: Universal intake of up to 40,000 IU vitamin D per day is unlikely to result in vitamin D toxicity.

VitaminDwiki has a number of excellent charts like the following on vitamin D3 dosing and loading doses to achieve a target 25(OH)D serum concentration of 50 to 70 ng/mL... 

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It's important to note that this 25(OH)D target range is for normal people... As CH'ers...  we're far from normal as Brew pointed out.

We suffer from a condition characterized by neurogenic inflammation... and so far, the data we've collected here at CH.com and from the online survey of CH'ers using the anti-inflammatory regimen with 10,000 IU/day vitamin D3 indicate we need an average target 25(OH)D serum concentration around 85 ng/mL ±10 ng/mL to remain pain free of cluster headaches.

It is also important to note that we are way out in front of conventional medical science dosing on vitamin D3 at 10,000 IU/day in order to maintain an average target 25(OH)D serum concentration of 85 ng/mL to prevent our cluster headaches. 

There are no other RCTs on this topic.  The best and only information on the safety and efficacy of the anti-inflammatory regimen with 10,000 IU/day vitamin D3 is right here at CH.com.  So far since December of 2010... I'm unaware of any reports of adverse reactions to this regimen that required medical attention...  and the efficacy is holding steady at 80%.

I've done some recent reading on an RCT reporting the efficacy of verapamil as a prophylaxis for episodic cluster headache sufferers...  See attached pdf file for more info.

Verapamil reduced attack frequency and the use of abortive agents in episodic cluster headache

Design:  Randomised {allocation concealed*},† blinded {clinicians, patients, and outcome assessors*},† placebo controlled trial with 2 week follow up.

Setting:  3 outpatient clinics in Italy.

Patients: 30 adults between 18 and 60 years of age (mean age 44 y, 90% men) who were outpatients and had a diagnosis of episodic cluster headache (International Headache Society criteria) with > 1 previous cluster period lasting > 1 month and who had been in a cluster period for < 10 days and had an expected duration of the remainder of the cluster period of >20 days.

Exclusion criteria were liver or kidney disease, cardiopathological findings contraindicating verapamil use, psychiatric disorder, use of antidepressants or antipsychotics, drug or alcohol abuse, or previous adynamicileus. Follow up was 100%.

Intervention:  After a 5 day run in period, patients were allocated to verapamil, 120 mg 3 times/day (n = 15), or placebo, 3 times/day (n = 15), for 2 weeks.

Main outcome measures:  Self reported frequency of cluster headache attacks and use of abortive agents.

Main results:  During the first week of treatment, the verapamil and placebo groups did not differ for median numbers of attacks/day (1.1 v 1.7) or abortive agents used/day (1.0 v 1.2).

During the second week of treatment, verapamil was more effective than placebo in reducing both the number of attacks (median 0.6 v 1.65/d, p < 0.001) and the number of abortive agents used (median 0.5 v 1.2/d, p < 0.004). Fewer patients in the verapamil group than in the placebo group were non-responders (ie, having a < 50% reduction in attack frequency) {p < 0.001}.  Side effects experienced during the treatment period were mild.

Verapamil v placebo for prophylactic treatment of episodic cluster headache at 2 weeks

Outcome         Verapamil     Placebo     RRR     (95% CI)
Non-response       20%          100%      80%    (53 to 93) 1 (1 to 2)

Because this RCT was done to the gold standard: randomized, blinded, placebo controlled...  it carries more weight as medical evidence than our online survey of CH'ers.

Data from that survey indicate 80% of the 75 paticipating episodic CH'ers experienced a favorable response with a significant (>50) reduction in the frequency, severity and duration of their CH and 62% experienced a sustained pain free response.

Most of the CH'ers in this survey who experienced a favorable response experienced that response in first week.

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You can draw your own conclusions...

Take care,

V/R, Batch

Hey Don,

Thanks for the update...  Glad this regimen is working well for you.  I do a burndown test of my 25(OH)D reserves a couple times a year by intentionally stopping the anti-inflammatory regimen until I feel a CH coming...

It usually takes 7 to 10 days for my CH to return if I was dosing at 10,000 IU/day vitamin D3 prior to starting the burn-down test.

The bottom line...  as CH'ers... episodic or chronic... we need to stay on this regimen year-round if we want to remain pain free...

Take care and thanks again for the update.

V/R, Batch

Hey Sue,

Good on you for picking up the script for the 25(OH)D lab test...  Brew has given you the right link to find the complete list of supplements and suggested dosing used in the anti-inflammatory regimen.

As to how long it can take to respond to this regimen, see the following chart.  This is data harvested in July 2013 from our online survey of CH'ers using the anti-inflammatory regimen with at least 10,000 IU/day vitamin D3.

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As you can see, 80% of the CH'ers CH'ers who respond to this regimen did so in 14 days or less.  A few respond in less than 24 hours... then there are others that have taken up to two months.

It's interesting to note that the response rate is roughly the inverse of the 25(OH)D response to dose of vitamin D3 as shown below:

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Near as we can figure... the response time depends on the serum concentration of 25(OH)D at the start of therapy... It also depends on any competing processes that consume 25(OH)D and the active hormonal vitamin D3 metabolite 1,25(OH)2D3 (calcitriol). 

After calcium homeostasis - the process of maintaining an optimum serum calcium concentration and building bone mineral density, our immune system is the next largest consumer of vitamin D3 and it's metabolites.

A cold, the flu and even a sub-clinical allergic reaction (no detectable symptoms), can consume available 25(OH)D very rapidly leaving an insufficient concentration to prevent cluster headache.

You've made a wise choice by starting this regimen... Please feel free to ask questions.

Take care,

V/R, Batch

Hey Hell-Jee,

Thanks for the update.  22 ng/mL is clearly vitamin D3 deficient...  Keep titrating up on the vitamin D3 to 25,000 IU/day by adding an additional 5,000 IU/day and be sure to take the Omega-3 Fish Oil and all the vitamin D3 cofactors.  When you get to 25,000 IU/day you can add a 50,000 IU loading dose once a week...  Stay on this dosing schedule for at least two weeks then you can drop the loading dose.

Given your response so far, you should be completely pain free in a few weeks. Be sure to see your PCP or neurologist to get the lab test for 25(OH)D again after a month on the accelerated vitamin D3 dosing schedule... 

Your target serum concentration of 25(OH)D should be 80 to 85 ng/mL.  Once you reach this serum concentration you can drop back to a maintenance dose of 10,000 IU/day vitamin D3.  That should hold you there.

Take care and please keep us posted.

V/R, Batch

Andy,

Good question...  The first thing to do is have your son see his PCP to discuss the anti-inflammatory regimen and schedule a lab test for 25(OH)D.  If that's going to take a while, most CH'ers start this regimen then get tested...

The basic regimen shown below works effectively for most CH'ers. 

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It's convenient as there are only three types of pills to take... two of each... 

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If there's no response after two weeks, even with an accelerated vitamin D3 dosing schedule... more magnesium may be needed up to the RDA of 400 mg/day.

What we've learned over the last year is that vitamin A (retinol) and vitamin K2 (MK-4 and MK-7) are also important vitamin D3 cofactors.  I take a Centrum Silver tablet or a tablet of the Safeway brand Century Senior 50+ Formula. It has a similar formulation.

Bottom line...  If there's no response to this regimen even with an accelerated vitamin D3 dosing schedule... add more magnesium and Omega-3 Fish Oil.  Magnesium malate, magnesium glycinate or magnesium citrate have a higher bioavailability than magnesium oxide.

It's also a good idea to get tested for 25(OH)D again after a month on this regimen.  That way you can adjust the vitamin D3 intake accordingly.

Take care and please keep us posted.

V/R, Batch