ShazBot! It sounds like we're approaching agreement... However, I think it's wise to review the bidding and rationale for the dosing strategies used in the anti-inflammatory regimen of vitamin and mineral supplements.
Just in case some of the comments have thrown a head & shoulder fake to readers coming late to this discussion... the Basic and Complete Anti-inflammatory Regimen Treatment Protocol and Dosing Guide is located at the following link:
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Let me start by saying the basic anti-inflammatory regimen amounts to a conservatively stacked deck as a CH preventative with respect to the supplement doses and their ratios. With the exception of the vitamin D3, the remaining supplements are at or below their respective Recommended Dietary Allowances (RDA).
I arrived at the composition of the present basic regimen after consulting with with experts in nutrition, endocrinology, and integrative medicine. As we gather more information, I expect there will be room for fine tuning the amounts and ratios of these supplements. The beauty of a forum like this is that there's room for differing opinions on this regimen... like taking more calcium or not taking any at all. What's even more important, is the rationale behind these opinions, and are the results repeatable.
That said, when we contrast the efficacy of this regimen with the leading standards of care preventative, verapamil, the present regimen is doing just fine. That 70% of the 100 + CH'ers who started this regimen have a significant reduction in the frequency and severity of their CH, and that 66% of them are pain free and remain that way trumps verapamil with at best 50% efficacy per the results of the Cluster Headache Survey 1134 of us took.
So let's review the present regimen. The suggested dose for vitamin D3 is 10,000 IU/day. This is a very safe therapeutic dose. That amount may be a little high for a maintenance dose for some CH'ers while others may require an even higher dose to stay pain free... and that suggests an even higher therapeutic dose... If you look at the following graph of 25(OH)D response to vitamin D3 dose, you'll see what I mean. It doesn't take too much imagination to draw another curve for a dose of 15,000 or 20,000 IU/day vitamin D3 to see that the initial rise in the slope of 25(OH)D concentration is steeper and that it arrives in the green zone at 60 ng/mL in much less time.
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I've overlaid lab test results for 25(OH)D from several CH'ers before and after going pain free using the anti-inflammatory regimen. What this graph tells us follows: For a given daily intake of vitamin D3, we reach a corresponding serum level of 25(OH)D, that it reaches equilibrium and stabilizes at a steady state value after 5 to 6 months. What it also tells us is the higher the daily intake of vitamin D3, the rise in 25(OH)D is faster, it reaches the green zone in fewer days, and the resulting stable serum level of 25(OH)D is higher after 5 to 6 months.
The important thing to remember about supplementing with vitamin D3 is that without a lab test for 25(OH)D, it's principal metabolite, our only measure of merit is the dose related response as evidenced by a favorable change in CH pattern, i.e., reduction in frequency and severity of CH with the goal of going completely pain free and staying that way.
The second point is to correlate lab test results of 25(OH)D concentrations to a change in CH pattern that's keeping the beast away if the level is high enough.
From the data I've collected thanks to many of you who've had this lab test and posted the results, the target therapeutic range to stay pain free appears to be 60-90 ng/mL (150-225 nmol/L) for most of us... Some may require an even higher concentration upwards of 120 ng/mL, (300 nmol/L) and some may require slightly less. This is the data I used to generate the green color band in the chart above.
What we do know at this point is there are CH'ers who's 25(OH)D concentration was 42 ng/mL and they were still experiencing frequent CH. I used this data to anchor the upper boundary of the pink color band in the above graph. I'd also like to point out that as more CH'ers try this regimen and have the lab test for 25(OH)D, these color bands will take on better resolution.
The real question now is what is the best dosing strategy to elevate our 26(OH)D concentration into the pain free green zone as safely and rapidly as possible without upsetting the apple cart by taking too much of one or another of the supplements and disturbing their balance.
The following graph from the most recent study by Garland et al, on vitamin D3 dosing and 25(OH)D response measured every six months as collected by the GrassRootsHealth D*Action study, paints an interesting picture:
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I've drawn a line from 60 ng/mL 25(OH)D concentration to the lower 95% probability boundary and from there down to the daily dose required to reach that concentration. From this you can see that in order to ensure the probability that 95% of the dosing population reaches a serum level of 60 ng/mL, they would need to dose at 20,000 IU/day.
Clearly calcium and the vitamin D3 cofactor minerals magnesium, zinc and boron play a role in optimum metabolism of vitamin D3 into 25(OH)D, and from the recent posts, the amount of calcium supplements and the cal-mag ratio also appears to be an important factor.
We also know from the results of several published studies on serum level 25(OH)D response to vitamin D3, that a therapeutic dose of 10,000 IU/day is safe and not likely to result in vitamin D3 intoxication associated with 25(OH)D levels of 200-300 ng/mL with hypercalcemia and hypercalciuria.
In fact, there are other studies that have shown that starting and 20 week serum levels of calcium were unchanged when taking vitamin D3 at 10,000 IU/day. The most recent study of the 25(OH)D response to vitamin D3 doses as high as 40,000 IU/day concluded that a long term sustained daily intake this high is also safe and unlikely to result in vitamin D3 intoxication.
At face value, that leaves us with a safe therapeutic vitamin D3 dosing range of 10,000 to 40,000 IU/day. However like so many other systems in nature, the law of unintended consequence comes into play when we upset the balance of these systems by increasing the quantity of one of the reactants in that process. For example, increasing the daily intake of vitamin D3 also drives more calcium into solution from all sources and if the extra calcium isn't available in the gut, this process takes it from our bones.
Calcium homeostasis, the processes by with the body maintains serum calcium levels in a narrow range of 2.2 to 2.6 mmol/L is much like other homeostatic processes in the body. These include the homeostatic processes that maintain our body temperature at 98.6º F, our arterial pH in a range between 7.35 and 7.45, and blood glucose levels between 64.8 and 104.4 mg/dL.
Accordingly, as calcium homeostasis can and will extract calcium from the bones in order to maintain optimum serum calcium levels if insufficient calcium is available in the gut from dietary sources, it's prudent to supplement with calcium when supplementing with vitamin D3. (See following link for a paper on calcium homeostasis, PTH and Calcitonin.)
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That begs the questions, How much calcium? and If I add calcium, how much magnesium should I take to maintain adequate vitamin D3 metabolism to make the 25(OH)D needed to remain pain free?
I'm not a doctor or a nutrition expert. However, in reviewing available information on this topic and talking with some experts, there are several recommendations for calcium supplements that range from 500 to 1000 mg/day. From what we've learned about the anti-inflammatory regimen, calcium citrate is the preferred form of calcium supplement to take and 500 mg/day appears to be adequate.
Magnesium supplements and the cal-mag ratio are another story. Suggested cal-mag ratios range from 2:1, 1:1 and 1:2. Moreover, there's no clear consensus. If you're taking two of the Kirkland brand of calcium citrate tablets, you're getting 500 mg/day calcium and 60 mg/day magnesium. (You're also getting the required zinc and boron). That may not be enough magnesium for some of us which gets us back to the question of how much more magnesium should we add?
The RDA for magnesium is 420 mg/day for men and 320 mg/day for women, and as magnesium is readily available in green leafy vegetables, whole grains, nuts, meat, starches, and milk, without a lab test, it's difficult to tell. From my experience, 200 mg of additional magnesium is fine but 400 mg starts getting iffy...
In reality, the answer here is easy... Your bowels will tell you when you've taken too much supplemental magnesium... In other words, it's like rolling the dice in a crap shoot... and that analogy is spot on... Take the right amount, you win, and everything works better. Take too much and you crap out... In other words, you'll find yourself taking small steps with great trepidation towards the dumper...
The reason for this behavior is simple... You'll get loose as a goose with explosive watery stool if you take too much magnesium.
That reminds me of Uncle Miltie... the comedian and actor Milton Berle, who joked about a commercial for the BVD brand of underware by saying... "At my age... I've done everything in my BVDs..." with a big smile...
I'll close on that note of bathroom humor... but I will make another request of the CH'ers who've tried this regimen, to take the Anti-Inflammatory Survey if they haven't already done so... We need this information and there are at least another 70 of you out there who haven't taken this survey.
Take care,
V/R, Batch
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