Thanks Rick,
You found out a lot of info already while I am still thinking of what happened to this trail! Oddly, it still says that they are recruiting patients. NIH must have some information on what the results of this study are since they funded it. It would be interesting to see if you get a reply from the PI and if so what she says!
It is a pity that NIH funded studies with a good potential like this one, vanish into thin air. May be a victim of another placebo effect???
Girija


QUOTE=reverett123;522932]That clinical trial, which should have been as straight-forward as it gets, was to be completed this past December. But I have searched pretty thoroughly and it seems to have vanished down the memory hole. A lot of hits in 2007 when it was announced but nothing since. I have emailed the contact asking about it and will let you know what I hear back.

The doc in charge was one Marian L. Evatt, MD, Assistant Professor of Neurology, Emory University, School of Medicine, and Assistant Chief of Neurology, Movement Disorders Program, Wesley Woods Geriatric Hospital, Inc, Atlanta .

Searching for her turned up a CE leture she gave less than three months ago titled: " Vitamin D and Neurologic Disorders". The lecture abstract is at http://www.cme-ce-summaries.com/fami...ce/fp5712.html

The section about PD says nothing at all about a major trial that should have been complete just 90 days earlier. That seems kind of odd. Hmmmm...[/QUOTE]

I wrote_
"I was wondering if I might get a brief update of this study. The information posted on clinicaltrials.gov is inconsistent in the proposed timeline.
Thank you-"

Just received_
"What information are you looking for and what is inconsistant in the proposed time line that you are speaking of."

I replied_
"
Thank you for the reply. What had confused me was that the original posting of the clinical trial projected that it would end in December of 2008. Yet the latest info indicates that you still needed participants. If that is so, I might be interested in helping since I am between Knoxville and Chattanooga. If, on the other hand, it is winding up I would like to know when it will be released/published so that I can use the information in my own regimen. I am in my 17th year and, while doing well, if something as basic as Vitamin D makes such a difference it would be foolish for me not to try it.

Again, my thanks. "

If she replies I will forward. Kind of an odd answer.

(Is it just me or something odd here?)


Sperin, Elaine F. wrote:
> Study is still recruiting iff you would be more specific in what information you are looking for would be glad to answer your questions.
> ____________________
> Elaine Sperin, LPN
> Research Coordinator
> Emory University
> Department of Neurology
> 404-728-4786

my reply:

Ms. Sperin-

Regarding the trial noted-
1) Seeing as the trial is still recruiting well past its original projected completion date, does this mean that it has not begun at all? If that is the case, has there been a revised schedule adopted?
2) Given the encouraging initial finding, the potential value to PD patients such as myself, and the relative simplicity of the trial, has something unforeseen come up to delay further work?

Thank you-
Richard Everett

Rick,
thanks again. It is odd to get one-liner replies. May be you could talk her directly?
Girija

LPN's aren't generally PI's - but her title is that of a coordinator - when I worked in research, at least a masters was required to coordinate anything ...and correct grammar and spelling were also valued skills....I doubt if this individual really knows - or is authorized - to tell you much (If that sounds snobby, I worked in very hierarchical settings). Obviously, there has been a delay, but who knows what? Any response? She sounds somewhat defensive.

Sasha

We're so eager for results that we forget the whole world isn't as into expediting research as we are....

From one of the author's other studies: "PARTICIPANTS: Participants were recruited into the study between May 1992 and March 2007. Every fifth consecutively enrolled PD patient was selected from the clinical research database." Not exactly in a hurry, huh? Maybe that's just the way they do things in her world...4:

Prevalence of vitamin d insufficiency in patients with Parkinson disease and Alzheimer disease.

Evatt ML, Delong MR, Khazai N, Rosen A, Triche S, Tangpricha V.

Arch Neurol. 2008 Oct;65(10):1348-52.

PMID: 18852350 [PubMed - indexed for MEDLINE]


Sasha

Also from the Emory web site:

The five-year grant will fund research at Emory's newly created Parkinson’s Disease Collaborative Environmental Research Center led by Gary W. Miller, PhD.

"Parkinson's disease has been linked to pesticide exposure, mitochondrial damage and altered storage of the neurotransmitter dopamine. Miller and his team will probe how environmental and genetic factors interact to alter these functions in dopamine neurons. ....

"This grant unites toxicologists, neurologists, biochemists, pharmacologists, statisticians and system biologists to determine how environmental factors influence Parkinson’s disease," says Miller, associate professor of environmental and occupational health, Rollins School of Public Health, Emory University, and study principal investigator....

Other investigators involved with the project include: Mahlon DeLong, MD, Dean Jones, PhD, Zixu Mao, MD, PhD, Tianwei Yu, PhD, Younja Park, PhD, and Stewart Factor, DO, all of Emory University; and Eberhard Voit, PhD, and Kurt Pennell, PhD, of the Georgia Institute of Technology."

Our PI is not listed. What does this mean???

Sasha,
The PI for this study is Dr, Evatt/ Rick's e mail replies are from a contact person. Link to NIH site is in my first post ooof this thread

girija

NCT ID ICMJE NCT00571285
Responsible Party Marian L. Evatt, Emory University
Secondary IDs ICMJE
Study Sponsor ICMJE Emory University
Collaborators ICMJE
Investigators ICMJE
Principal Investigator: Marian L Evatt, MD, MSc Emory University
Information Provided By Emory University
Verification Date December 2007

The five-year grant will fund research at Emory's newly created Parkinson’s Disease Collaborative Environmental Research Center led by Gary W. Miller, PhD.

"Parkinson's disease has been linked to pesticide exposure, mitochondrial damage and altered storage of the neurotransmitter dopamine. Miller and his team will probe how environmental and genetic factors interact to alter these functions in dopamine neurons. ....

"This grant unites toxicologists, neurologists, biochemists, pharmacologists, statisticians and system biologists to determine how environmental factors influence Parkinson’s disease," says Miller, associate professor of environmental and occupational health, Rollins School of Public Health, Emory University, and study principal investigator....

Other investigators involved with the project include: Mahlon DeLong, MD, Dean Jones, PhD, Zixu Mao, MD, PhD, Tianwei Yu, PhD, Younja Park, PhD, and Stewart Factor, DO, all of Emory University; and Eberhard Voit, PhD, and Kurt Pennell, PhD, of the Georgia Institute of Technology."

Our PI is not listed. What does this mean???[/QUOTE]

ABSTRACT OF VIT D STUDY BY DR. EVATT (funding awarded last year - bolding mine)


Title: Vitamin D Insufficiency: Prevalence and Clinical Correlates in the
DATATOP Cohort
Principal Investigator: Marian Evatt, MD, MS, Assistant Professor of Neurology, Emory University, Atlanta, Georgia.
Abstract: Vitamin D has been found to play a far wider role than maintenance of bone health, including immunity and cell proliferation and differentiation, and it has recently been proposed that low vitamin D levels may play a role in the pathogenesis of PD. Both 1α-hydroxylase, the enzyme responsible for activating vitamin D, and the vitamin D receptor (VDR), are widely distributed in areas of the brain known to be affected in PD and other disorders of gait and balance. We have found a significant decrease in vitamin D levels in patients with PD compared with matched healthy controls. However, the potential role of vitamin D in PD and other neurodegenerative diseases has not yet been widely investigated, particularly in de novo PD. The objectives of this proposal are to examine vitamin D status in patients with newly diagnosed PD and to assess the motor and non-motor correlates of hypovitaminosis D. The primary hypothesis of this study is that vitamin D levels at DATATOP baseline are inversely correlated with PD-related motor and non-motor signs and symptoms, as well as disease progression. The specific aims of this study are: to estimate the prevalence of hypovitaminosis D, as well as the mean serum 25-hydroxyvitamin D [25(OH)D] level and variance in patients with de novo PD and to determine whether vitamin D status changes significantly over a two-year period. We will also determine whether vitamin D status, as measured by 25(OH) D, correlates with measures of motor and non-motor function in patients with de novo PD, and whether baseline vitamin D status correlates with progression of PD disease motor and non-motor function measures (specifically, measures of cognitive and affective symptoms) and time to need for levodopa from baseline.

link to Emory site: http://www.parkinson-study-group.org...ouncements.asp

What I call the "lack of urgency" in the science community.

Here we have a common substance with a high safety profile. An identified extreme deficiency in the patient population. An initial proposal to simply give some patients the vitamin over a two year period and see if it helps.

Now that initial, sane proposal has disappeared and has been replaced with a plan that will stretch things out for ten to fifteen years, assure tenure for the academics, keep the grant money flowing, and not tick off the pharma interests that seem to provide a lot of money to Emory.

Everyone benefits except the patient.