Vitamin D in Prostate 2.3

[MrNews]

I am taking the Prostate 2.3 formula on the advice of my urologist, after a slow but steady increase in PSA levels over several years, and a biopsy finding of a single ASAP. I've been on the supplement for about six months, and a subsequent biopsy came back benign. PSA levels are still being monitored.

My concern is the amount of Vitamin D contained in the Prostate 2.3 formula. It is listed as 2400 IU per serving (1200 IU per capsule). However, a recent (April '10) article in Nutrition Action Healthletter (from the Center for Science in the Public Interest), in noting a study finding a possible link between Vitamin D blood levels and reduced risk of colon cancer, also pointed out that "a few other studies have s***ested that high blood levels of Vitamin D may be linked to a higher risk of pancreatic cancer." (http://cancerres.aacrjournals.org/cgi/content/abstract/66/20/10213.) The magazine editors recommend Vitamin D supplementation of between 700 and 1000 IU per day, but caution "don't assume that more is better."

Given that your Prostate 2.3 formula contains 2400 IU of Vitamin D per serving, 600% of the Daily Value (as listed on the label), and some studies have linked higher levels of D (in certain populations) to increased risk of pancreatic cancer, I would be interested to know if recent studies on Vitamin D supplementation are being evaluated by your staff, and if the Vitamin D level in Prostate 2.3 formula is being re-considered?

Thank you for passing this information along to your scientific & medical staff.

[theralogix]

Dear MrNews-

Thanks for your question. The study that you link to is a nested case control study. In a group of male Finnish smokers, cases (those who were diagnosed with pancreatic cancer) were compared to controls (those who did not get pancreatic cancer) to see if associations could be made. What I find interesting about this paper is that the average 25(OH)D level among the cases and controls were both deficient. In general, 25(OH)D levels less than 20ng/mL (50 nmol/L) are considered vitamin D deficient. The average and range of 25(OH)D levels in the cases were 49 nmol/L (38-68 nmol/L) and in controls 46 nmol/L (27-62 nmol/L). The range of levels among both groups would be considered deficient to insufficient (generally 20-32 ng/mL or 50-75 nmol/L). So, we can’t really generalize these results to non-smokers or populations with more adequate vitamin D status. In addition, the authors of this study conducted another case-control study more recently, and did not find a link between vitamin D status and pancreatic cancer. A review article by the same lead author stated that “recent prospective epidemiological studies of higher predicted vitamin D status score and vitamin D intake and pancreatic cancer risk s***est protective associations.”

As for the research publications regarding vitamin D and prostate cancer, we have links to several PubMed abstracts on the journal references page of our web site that you may be interested in reading. Please click here- http://www.theralogix.com/index.cfm?fa=products.prostate.references&dvsn=urology#Vitamin D References (http://www.theralogix.com/index.cfm?fa=products.prostate.references&dvsn=urology%23Vitamin%20D%20References)
In addition to studies associating a low vitamin D blood level with an increased risk of prostate cancer, higher blood levels have been associated with a better prostate cancer prognosis, and in a small pilot trial of men with prostate cancer recurrence, 2000 IU was shown to slow the rate of PSA rise. A good review article of the potential role of vitamin D in cancer prevention can be found by clicking the following link, then choosing the full text version http://www.ncbi.nlm.nih.gov/pubmed/16380576?dopt=Abstract (http://www.ncbi.nlm.nih.gov/pubmed/16380576?dopt=Abstract)

While CSPI is correct that more clinical trials are needed to determine the exact dose of vitamin D that is beneficial, we know that 2400 IU is a safe dose, and most vitamin D experts agree that 2000 IU per day is a good maintenance dose for most adults. Adequate vitamin D levels are important for bone health, immune function, neuromuscular function, and may play a role in various other conditions. If you are worried that your vitamin D level is too high, I would recommend having it checked.

We, and our Medical Advisory Board, review the vitamin D research on a continual basis, and based on the existing research, are not planning to change the dose of vitamin D in Prostate 2.3. The board did decide, in late 2008, to increase the amount of vitamin D from 1600 IU to 2400 IU per day after reviewing all of the vitamin D literature at that time.

Please let me know if you have any further questions or concerns.

Best regards,

Tiffany Graham, MPH, RD, LD
VP for Research and Education
Theralogix, LLC
Ph: 301-610-9940, ext. 3003
Fax: 301-610-9941
http://www.theralogix.com (http://www.theralogix.com/)

[MrNews]

Thank you for your prompt response, Tiffany.

Yes, I see the subsequent (Feb 2009) study by Ms. Stolzenberg-Solomon which did NOT find a positive correlation between higher Vitamin D concentration and pancreatic cancer. It does seem that much of the research is in agreement that (limited) daily sun exposure is the best source of Vitamin D synthesis in the body, and those in northern climes get less of it. Obviously, many variables are at play, including location, genetics, race, age, diet, smoking, and so on.
While there does not seem to be any definitive research into the "optimum" levels of serum D, the overall research on the possible cancer preventative effects of Vitamin D remains unclear and/or inconclusive.

At present (2010), the NIH is still recommending 400 IU of daily Vitamin D supplementation for persons age 51-70, while the 2005 Dietary Guidelines for Americans recommends that "older adults, people with dark skin, and people exposed to insufficient sunlight should consume extra vitamin D (1,000 IU) from vitamin D-fortified foods and/or supplements." So 2400 IU still seems slightly high to me, although it is nowhere near the dosages known to cause toxicity.

One s***estion I could make (only partly tounge-in-cheek) is that Theralogix create Prostate-North and Prostate-South formulae, with lower levels of Vitamin D in the South version, for persons living in sunnier locales who obtain more of their D though UV exposure and/or D-fortified foods. A choice is always good.

Again, thank you for your quick response, and Theralogix' ongoing review of all available literature on this subject.

[theralogix]

MrNews-

Thank you for your s***estions! I got a laugh out of the Prostate N and S versions, but you are certainly correct (and may have a great product idea!) that the D3 intake needed to maintain a normal 25(OH)D level depends on several factors, geography being a major one. It will be interesting to see what the IOM sets as the new recommendations once the current ones are reviewed.

You may have already read these studies, but I have pasted a couple of links to abstracts that you may find interesting. One is in regards to prostate cancer specifically, and the second is a dose-ranging study that assessed the intakes needed to reach and maintain 25(OH)D levels of 32-80 ng/mL (in a population on Long Island, NY).

http://www.ncbi.nlm.nih.gov/pubmed/19156140?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum (http://www.ncbi.nlm.nih.gov/pubmed/19156140?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum)

http://www.ajcn.org/cgi/content/abstract/87/6/1952 (http://www.ajcn.org/cgi/content/abstract/87/6/1952)

Best,
Tiffany

[MrNews]

I continue to be concerned about the high level of Vitamin D in the Prostate 2.3 formula. Additional studies keep coming in which indicate that an optimum level of D may help protect against osteoporosis and possibly colon cancer, but that higher levels not only do not offer additional protection, but at very high levels, may increase the risk of pancreatic cancer. Here is a recent review of 10 studies from the American Journal of Epidemiology:
http://aje.oxfordjournals.org/cgi/content/full/172/1/4

Since the prevailing research shows that taking 700-1000 IU of Vitamin D daily typically leads to blood levels around 30 ng/mL, considered optimally protective, I am reducing my daily dosage of Prostate 2.3 to one pill per day, containing 1200 IU. It seems prudent, although I have not specifically had my Vitamin D blood levels tested, to go by current research results, and not go overboard on the D. I would strongly urge Theralogix to reformulate this supplement with 500-600 IU of D per capsule, just slightly above the RDA limit.

[theralogix]

MrNews,

Thanks for your post. I reviewed the Vitamin D Pooling Project of Rarer Cancers papers recently, including the pancreatic cancer meta-analysis. The ATBC (2006) and PLCO (2009) studies, which we discussed in the earlier posts, were included in the meta-analysis, although the cut-point for the highest quintile of 25(OH)D is higher in the meta-analysis than the original PLCO study so that is the reason for the difference in OR. The pooled estimated increase in pancreatic cancer risk was among those with 25(OH)D levels >40ng/mL. We will certainly review this paper at our next Medical Advisory Board meeting, along with other vitamin D studies. Our Board previously chose to increase the dose to 2400 IU based on a dosing study- http://www.ajcn.org/cgi/content/abstract/87/6/1952 (http://www.ajcn.org/cgi/content/abstract/87/6/1952), along with other vitamin D studies.

I would recommend that you have your 25(OH)D level checked to see what level you are maintaining with an intake of 2400 IU per day, so that you can know exactly what dose you need to maintain a normal level.

The vitamin D recommendations do vary among the experts, with some recommending the lower doses of 700-1000 IU and some recommending significantly higher doses to maintain a level >30ng/ml. For many adults, the lower dose would not maintain a normal blood level without adequate sun exposure, which stresses the importance of having your serum level checked.

Thanks again for your s***estion, which we will review.

Best regards,
Tiffany

Tiffany Graham
VP for Research and Education
Theralogix, LLC

[MrNews]

Thanks for that Tiffany. I just discussed Vitamin D levels with my primary care physician, who assured me that D is one of the safer supplements (of course he WAS trained around 1960 and doesn't keep up...). He says the only risk he's aware of with extremely high levels of D is kidney stones (calcium?), but he agreed to order a Vitamin D blood level test, which I will get in early December. So I'll have a reading on my D level after 14 months of 2400 IU daily supplementation. We do get a lot of sunlight here in Tampa Bay.... LOL

On a positive note, my latest PSA reading is down 20% (from 3.4 to 2.7) after 68 months of slow but steady increases. My urologist just shr***ed his shoulders and said "We'll just keep an eye on it, and an annual test is probably adequate." After two biopsies failed to find any active cancer, I think he's losing interest in my case, LOL. My next PSA test is early December (probably too soon), and then probably 12 months after that. I do have some family history [one grandfather died WITH prostate cancer (not OF it)] but my dad is still living, with prostate cancer, at age 92.

Anecdotally, one could say the Theralogix Prostate 2.3 formula lowered my PSA test reading. But I probably won't. I'll keep taking the full dose, eating healthy (lots of cooked tomato sauce- yum!) and see what happens.

Cordially,
--Eugene

[theralogix]

Hi Eugene,

Thanks for the response and the other information. In regards to vitamin D and kidney stones, your doctor is correct that very high serum levels of vitamin D (generally greater than 100 ng/mL) can result in high blood calcium levels (hypercalcemia) and increase the risk of kidney stones. However, it takes a very large dose of vitamin D consistently to have this effect. In most adults, it may take more than 10,000 IU a day consistenly over time to reach such high blood levels.

If you get your 25(OH)D level (vitamin D test) back, and would like to let me know your level, I'd be interested.

Have a nice weekend.

Tiffany

[MrNews]

My doctor ordered a Vitamin D, 25-Hydroxy test, which was performed 12/6/10, and came back with a level of 25.1 ng/mL, below range. The recommended range (according to LabCorp) is 32.0 - 100.0 ng/mL. My PCP (having no idea what I'm taking) s***ested I supplement with 1000 units of Vitamin D per day. I pointed out that Prostate 2.3 (which I'm on through February, when I should finally get some 2.4) has 2400 IU per daily dose (2). He said: "Oh. Then get more sun." LOL

Oh, and my serum Calcium level was also a tiny bit low; not sure if that could be related. But PSA was only up 7.4%, and at 2.9 ng/mL, is still well within range (0-4), and actually back down to where it was almost 30 months ago. So, no prostate worries for the moment...

[theralogix]

Hi,

Thanks for the update. Interesting that your 25(OH)D level is slightly low, but everyone responds differently to vitamin D supplementation and it may take more than 2400 IU vitamin D per day to keep you at 32 ng/mL or above. Adding the 1000 IU that the doctor recommended is an option.

The Institute of Medicine's most recent report concluded that a "normal" blood level range is 20-50 ng/mL, although the National Osteoporosis Foundation reported (in response to IOM) that they still considered 32 ng/mL as the low end of the normal range, in regards to optimal bone health.

Serum calcium and D are related, and although I don't know why your level was slightly low it could be because the serum D is low (although, as discussed, some would argue that you are within the normal range for vitamin D).

Good to hear that there are no prostate worries for now.

Take care,
Tiffany