Could not edit, so just deleted entire post, will try again here:
Thx for the link! Looks pretty good to me so far, though the full study won't really be available for scrutiny until May.
"In a new randomized, controlled clinical trial his team assigned 37 men undergoing elective prostatectomies either to a group that received 4,000 U of vitamin D per day, or to a placebo group that didn't receive vitamin D. The men's prostate glands were removed and examined 60 days later. ................
Preliminary results from this study indicate that many of the men who received vitamin D showed improvements in their prostate tumors,
whereas the tumors in the placebo group either stayed the same or got worse.
Also, vitamin D caused dramatic changes in the expression levels of many cell lipids and proteins, particularly those involved in inflammation. "Cancer is associated with inflammation, especially in the prostate gland," says Hollis. "Vitamin D is really fighting this inflammation within the gland."...................................................................................................................................
This was only 60 days of supplementation! I'm looking forward to the availability of the full report. Previous studies on men under AS by these same researchers at Department of Radiation Oncology, Medical University of South Carolina, have also shown very interesting results(low risk only):
www.ncbi.nlm.nih.gov/pubmed/22508710 (abstract)
www.ncbi.nlm.nih.gov/pmc/articles/PMC3387395/ (full text)
Objectives:
The objective of the study was to determine whether vitamin D3 supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.
Design:
In this
open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.
)Bill asks:What is this "Investigational New Drug 77,839" business? Are they hoping to get Vitamin D3 declared an FDA approved/controlled drug? This reminds me at first blush of the studies I have posted about
the FDA orphan drug Apatone, AKA Vitamin C/Vitamin K 100:1. Oh well, different subject.)
......
Setting:
All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.
Patients and Other Participants:
All subjects had a diagnosis of low-risk prostate cancer. Fifty-two subjects were enrolled in the study, 48 completed 1 yr of supplementation, and 44 could be analyzed for both safety and efficacy objectives.
Intervention:
The intervention included vitamin D3 soft gels (4000 IU).
Main Outcome Measures:
Adverse events were monitored throughout the study. PSA serum levels were measured at entry and every 2 months for 1 yr. Biopsy procedures were performed before enrollment (for eligibility) and after 1 yr of supplementation.
Results:
No adverse events associated with vitamin D3 supplementation were observed. No significant changes in PSA levels were observed. However, 24 of 44 subjects (55%) showed a decrease in the number of positive cores or decrease in Gleason score; five subjects (11%) showed no change; 15 subjects (34%) showed an increase in the number of positive cores or Gleason score.
Conclusion:
Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D3 supplementation at 4000 IU/d.
(Bill adds:Yep, it is a medicine, just like Apatone!) :
Study medication
Food and Drug Administration Investigational New Drug no. 77,839 was granted for clinical studies designed to assess the effect of vitamin D3 (4000 IU/d for 1 yr) on subjects with early-stage prostate cancer. The vitamin D3 (cholecalciferol) was manufactured by J. R. Carlson Laboratories, Inc. (Arlington Heights, IL).
Clinical trial study design
The
open-label study enrolled 52 eligible subjects. Forty-eight subjects completed the study and were included in the safety analysis; these subjects had complete PSA laboratory results for inclusion in the evaluation of changes in PSA. Forty-four subjects had both baseline and repeat biopsy (as part of their standard of care) to compare the number of positive cores and Gleason score with baseline, after completing vitamin D3 supplementation. All subjects had study visits every 2 months for 1 yr to measure serum levels of 25(OH)D, PSA, phosphorus, and PTH, plus complete blood count, basic metabolic panel, and urinary calcium to creatinine ratio (to rule out any potential toxicities from vitamin D3 supplementation). In addition, circulating levels of vitamin D3 (cholecalciferol) and 1,25(OH)2D (calcitriol) were measured at baseline and exit in 19 subjects for whom extra serum samples were available.
Historical control subjects
From an institutional (MUSC) database of more than 700 patients diagnosed with prostate cancer within the last 5 yr, we identified 19 control subjects who were under active surveillance, underwent repeat biopsies, and met all eligibility criteria of the
open-label clinical trial, except that they received no vitamin D3 supplementation. We selected only patients who had their follow-up biopsy at 10 months or later after their initial positive biopsy to ensure comparability with the timing of the follow-up visit of the patients in the
open-label trial. All subjects who met eligibility criteria were included. From these control subjects, we abstracted information on their serum PSA levels and assessment of tissue biopsy specimens...........................
Here is a graph from the study:
www.ncbi.nlm.nih.gov/pmc/articles/PMC3387395/figure/F2/ It shows that (CI in parentheses): 34% of all subjects (0.20, 0.50); 45% of vitamin D-deficient subjects (0.17, 0.77); and 30% of nondeficient subjects (0.16, 0.49) Progressed AND
55% of all subjects (0.39, 0.70); 36% of vitamin D-deficient subjects (0.11, 0.69); and 61% of non-deficient subjects (0.42, 0.77) improved.
Another graph:
www.ncbi.nlm.nih.gov/pmc/articles/PMC3387395/figure/F3/ which shows that of patients who progressed, 61% were in the control group(no Vitamin D) and 35% got the VitD. Of the group showing improvement on repeat Bx, 22% were in the no Vit D group, 55% got the 4000 iu daily Vit D.
Or maybe this is the best graph:
www.ncbi.nlm.nih.gov/pmc/articles/PMC3387395/figure/F4/On the left (A) are the supplemented, and on the right(B) are the controls. While there are some in each group that either improve or get worse, look at the thick solid black lines which are the fitted estimate including all data within 48 months of baseline... In the treated group, these black line( number of positive cores) only points down(decreases) with increasing time, whereas the fitted estimate for the control(no Vitamin D) group only points up(increases).
Looks reasonably encouraging to me, at least until another study comes out debunking it! ( Seems to me like the studies debunking always make the news for some reason, you don't have to search for them)
Can't wait for the details on the RCT. Always hopeful, but often disappointed am I! ( also, I think I am going to take a Vitamin D, didn't have one today)
Bill in MS
Post Edited (BillyBob@388) : 3/23/2015 8:25:25 AM (GMT-6)