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Phase I/II Vitamin D Data

Postby Cyclops » Thu Oct 30, 2008 1:26 am

From the ECTRIMS website:

Cyclops

A Phase I/II dose-escalation trial of oral vitamin D3 with calcium supplementation in patients with multiple sclerosis
J. M. Burton1; S. Kimball2; R. Vieth2; A. Bar-Or3; H. Dosch4; L. Thibault5; S. Kilborn5; C. D'Souza6; R. Cheung4; M. Ursell7; P. O'Connor1
1. St. Michael's Hospital, Toronto, ON, Canada.
2. Mount Sinai Hospital, Toronto, ON, Canada.
3. Montreal Neurological Institute, Montreal, QC, Canada.
4. Hospital for Sick Children, Toronto, ON, Canada.
5. McGill University, Montreal, QC, Canada.
6. University of Toronto, Toronto, ON, Canada.
7. Etobicoke General Hospital, Etobicoke, ON, Canada.



Increasing distance from the equator, low UV radiation and low serum 25-hydroxyvitamin D [25(OH)D] are associated with increased multiple sclerosis (MS) prevalence and risk. While this relationship provides insight into prevention, it begs the question, ‘Is vitamin D3 (VD3), known to have immunoregulatory properties, beneficial in established MS?’ To answer this, a safe, effective dose must be determined.

To characterize the safety profile of high-dose oral VD3 in MS.

A prospective controlled 52-week trial matched MS patients for demographic and disease characteristics, randomizing them to treatment or control groups. Treatment patients started VD3 at 4000 IU/day and escalated over 28 weeks to 40 000 IU/day. This was followed by maintenance with 10 000 IU/day for 12 weeks, 4000 IU/day for 8 weeks and a 4-week wash-out, translating into roughly 14 000 IU/day over 52 weeks. Calcium (1200mg/day) was given throughout the trial. The primary endpoint was mean change in serum calcium in treatment patients at each VD3 dose, and a comparison of calcium between treatment and control groups. Secondary endpoints included 25(OH)D, urine calcium/creatinine (Ca/Cr) and PTH. Cytokines, lymphocyte response and matrix metalloproteinase-9 were also measured, as were Expanded Disability Status Scale (EDSS) and relapses.

Forty-nine patients were enrolled (25 treatment, 24 control) with mean age 40.5 years (21–54 years), EDSS 1.34 (0-6.0) and 25(OH)D 78nmol/l (38–154). No abnormalities or differences in serum calcium, urine Ca/Cr or PTH occurred, nor were there differences in calcium between groups. Despite a maximum mean 25(OH)D of 413nmol/l (66–729), no significant clinical or biochemical adverse events occurred. A greater proportion of treatment patients had stable/improved EDSS vs. control patients (p=0.018). Treatment patients also had fewer relapses and a greater reduction in relapse rate vs. controls. Immunological data will be presented.

High-dose VD3 (~10 000 IU/day, possibly higher) in MS is safe and tolerable, with evidence of clinical improvement.
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Re: Vitamin D News

Postby cheerleader » Thu Oct 30, 2008 6:18 am

Edit...
just reread the thread and noticed NHE posted the article last June. There's been alot of press on vit. D in the past few months-


"Exactly how low vitamin D levels might contribute to heart problems and deaths from other illnesses is uncertain, although it is has been shown to help regulate the body's disease-fighting immune system, he said."

Thanks for the links guys. That quote from the article is interesting. We DO have research linking vitamin D to endothelial dysfunction.

Many doctors now understand that vitamin D deficiency leads to oxidative stress, artherosclerosis, and heart disease. Vitamin D supplementation improves lipid peroxidation and heals the endothelium.
http://www.endocrine-abstracts.org/ea/0 ... 14p275.htm
http://ajpheart.physiology.org/cgi/cont ... 116.2008v1

This is no longer a mystery...the endothelium connects every system in the body, from vasculature to the blood brain barrier. And vitamin D supplementation can help heal breeches in this system. The institute's daily rec. is WAY too low...we're doing 4,000IU daily, and the ECTRIM study shows 10,000IU is safely tolerated.
AC
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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What about calcium with Vit D?

Postby Wonderfulworld » Mon Dec 01, 2008 12:57 pm

Hi
I am taking 1600 IU Vit D supplement per day. Does anyone know what's the take on calcium?
I do eat quite a lot of dairy now that I'm off Best Bet, and my multi-vit has about 20% RDA calcium.
Does anyone know if there is any potential problems from not taking calcium with Vit D, or is it ok?
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Postby notasperfectasyou » Mon Dec 01, 2008 2:45 pm

In our study, calcium supplementation was associated with reduced 1,25-(OH)2 vitamin D levels, presumably because the high calcium intake suppressed 1-hydroxylase activity in the kidney, inhibiting the formation of 1,25-(OH)2 vitamin D (46). The decrease in 25-(OH) vitamin D levels in both study groups may well have been a consequence of the reduced intake of dairy products, the main source of dietary vitamin D, during the trial.


This was the best I could do on the fly. You might want to read this carefully as I really didn't understand the main ideas. It's called: Vitamin D, Calcium Supplementation, and Colorectal Adenomas: Results of a Randomized Trial

can you make sense of this?

Ken
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Postby jimmylegs » Mon Dec 01, 2008 3:10 pm

take your d3 with 1200mg per day calcium. you need 600-1200mg per day magnesium with that also. and some zinc. you can take the d3 and the calcium at the same time. you need to split up the mag dosage. take some with the d3 and some away.

i think you can screw up your bones if you take d3 without calcium and magnesium. it needs it for the internal biochem. if you take it and don't provide cal and mag, it will leach it from your tissue, meaning your bones. i don't think it was a coincidence that after i started megadosing D3 and didn't get enough minerals, the next time i was at the dentist, i hear about bone loss in my jaw.

i can't spend the time looking up the journal refs to go with this but a search of pubmed or the forums here should turn up some good reading. just search for vitamin D, d3, anything like that
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Postby patientx » Mon Dec 01, 2008 6:04 pm

This is interesting. I was doing some searches today on Vitamin D, and I came across this article

http://jn.nutrition.org/cgi/content/abs ... 29/11/1966[url]

(I know, it's everyone's favorite mouse model, but still...)

I haven't read through the article yet, but it seems relevant to the topic.

I found this while I was searching for information on the 1,25 vitamin D versus the 25 OH form. When I was first being worked up, I had blood tests that showed I was low for the 25 OH form, and high for the 1,25 form. I am trying to figure out what this means. [/url]
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VIT D vs A

Postby Cojack » Thu Dec 04, 2008 2:51 pm

FYI,

Dr Cannell from The Vitamin D Council recently sent a newsletter
cautioning the use of 'cod liver oil' -- specifically the vitamin A
aspect.

Here's the link if you are interested:

http://www.vitamindcouncil.org/newslett ... mber.shtml

This is fairly interesting...

Jack
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Postby jimmylegs » Thu Dec 04, 2008 3:29 pm

it's true that caution is required when taking products that label one nutrient and not necessarily all. or even if all factors are labelled but you only take it for one of many..

CJ have you been taking d3 over the last while? if so, may i ask how much you take, how often, and for what overall time period you have been doing so? thanks :)
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Postby Cojack » Fri Dec 05, 2008 1:25 pm

Jimmy Legs,

I assumed you were male for awhile there... :) ...I'm still in the trial stage of this experiment..and really don't have a clue as to how much/or when/or in what combination....i think in the article cited yesterday it said 1,000 IU per 25lbs of body weight....that seems to be safely supported to me...especially compared to the amount our bodies make in the sun...I'm actually going to start using a sun bed/i hate them/but apparently they're a good source....i haven't even been tested for my levels yet...another good idea...

cheers,

jack
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Postby jimmylegs » Fri Dec 05, 2008 1:30 pm

hi jack

Jimmy Legs, I assumed you were male for awhile there.

not uncommon :)
it's a seinfeld joke, i've had to sit thru so many :S

re sun bed, make sure it's the right wavelength uvb!

and testing to monitor is very wise, good call :)

so you never took any yet huh. what are your symptoms all in all, if you don't mind me asking?

cheerio
JL
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Postby Cojack » Fri Dec 05, 2008 2:39 pm

JLeggs,


I've been taking about 4,ooo but will up it to 6,000...u can ck out the lovely symptom chart in the INTRO section....they evolve rather quickly/so i hate declaring them...(i'm still subclinical-they want to wait a bit and see how it plays out) so i'm out in the cold/save you lovely I-Net souls...

Jack
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Postby Wonderfulworld » Mon Dec 08, 2008 5:26 am

I too went for sunbeds for a while to up my vit d levels. Never again. My skin aged, more moles appeared, there were changes to existing moles and overall my skin has lost "bounciness" and is drier and wrinklier.

I think you should up your vit d with diet and careful supplementation - just my thoughts.
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Postby Wonderfulworld » Mon Dec 15, 2008 1:50 pm

Sorry, some time went by and I never thanked those who replied to my question.
So...thanks! :)
I did need to add cal/mag/zinc so appreciate the replies, thanks again.
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Home test for vitamin D content - $65

Postby Nick » Wed Dec 31, 2008 11:49 am

The Vitamin D Newsletter
December 28, 2008

The Vitamin D Council is happy to announce that we havepartnered with ZRT Laboratory to provide an inexpensive, $65.00, in-home, accurate, vitamin D [25(OH)D] test. The usual cost for this test is between $100.00 and $200.00.

If you read this newsletter, you know about our interest in accurate vitamin D testing. In the next few weeks, you may read about the Vitamin D Council's quest for accurate vitamin D blood tests in the national media. Before we partnered with ZRT, we verified, repeatedly, that ZRT provides accurate and reliable vitamin D tests and that their method corresponds very well to the gold standard of vitamin D blood tests, the DiaSorin RIA.

Our ZRT serviceis not just inexpensive, it means no more worrying about your doctor ordering the right test or interpreting it correctly. You buy the test kit on the internet or by phone, a few days later the kit comes in the mail, you or a nurse friend do a finger stick, collect a few drops of blood, and send the blotter paper back to ZRT in the postage paid envelope provided with the kit. A week later you get results back in the mail and know accurate 25-hydroxy-vitamin D levels of you and your family.

For every test you order,ZRT will donate $10.00 to the Vitamin D Council. Please read the new page hyperlinked below on our website as it both explains the procedure and how to order the test.

http://www.vitamindcouncil.org/health/d ... ient.shtml

Executive summary: keep your family's 25-hydroxy-vitamin D blood test above 50 ng/ml, year around. Most adults need at least 5,000 IU per day, especially this time of year. Most children need at least 1,000 IU per day per every 25 pounds of body weight. Bio Tech Pharmacal provides high quality and inexpensive vitamin D. Currently Bio Tech Pharmacal is providing vitamin D for numerous scientific studies. To see their prices and for ordering, click the hyperlink below.

http://www.bio-tech-pharm.com/catalog.aspx?cat_id=2

As a gift to our readers for the New Year, Thorne publications have provided a free download to a basic paper aboutvitamin D. I wrote it earlier this year for educated lay people as well as health care practitioners. Please read this paper carefully, your family's well-being, even lives, may depend on you understanding it.

http://www.thorne.com/altmedrev/.fulltext/13/1/6.pdf

Seasons Greetings
John Cannell, MD
vitamindcouncil.org


Thank you for subscribing to the Vitamin D Newsletter from the Vitamin D Council. The Vitamin D Council is a non-profit trying to end the epidemic of vitamin D deficiency. Please reproduce this newsletter and post it on Internet sites. Remember, we are a non-profit and rely on donations to publish our newsletter and maintain our website. Send your tax-deductible contributions to:

The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422
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Home test for serum vitamin D content - $65

Postby Nick » Wed Dec 31, 2008 11:51 am

The Vitamin D Newsletter
December 28, 2008

The Vitamin D Council is happy to announce that we havepartnered with ZRT Laboratory to provide an inexpensive, $65.00, in-home, accurate, vitamin D [25(OH)D] test. The usual cost for this test is between $100.00 and $200.00.

If you read this newsletter, you know about our interest in accurate vitamin D testing. In the next few weeks, you may read about the Vitamin D Council's quest for accurate vitamin D blood tests in the national media. Before we partnered with ZRT, we verified, repeatedly, that ZRT provides accurate and reliable vitamin D tests and that their method corresponds very well to the gold standard of vitamin D blood tests, the DiaSorin RIA.

Our ZRT serviceis not just inexpensive, it means no more worrying about your doctor ordering the right test or interpreting it correctly. You buy the test kit on the internet or by phone, a few days later the kit comes in the mail, you or a nurse friend do a finger stick, collect a few drops of blood, and send the blotter paper back to ZRT in the postage paid envelope provided with the kit. A week later you get results back in the mail and know accurate 25-hydroxy-vitamin D levels of you and your family.

For every test you order,ZRT will donate $10.00 to the Vitamin D Council. Please read the new page hyperlinked below on our website as it both explains the procedure and how to order the test.

http://www.vitamindcouncil.org/health/d ... ient.shtml

Executive summary: keep your family's 25-hydroxy-vitamin D blood test above 50 ng/ml, year around. Most adults need at least 5,000 IU per day, especially this time of year. Most children need at least 1,000 IU per day per every 25 pounds of body weight. Bio Tech Pharmacal provides high quality and inexpensive vitamin D. Currently Bio Tech Pharmacal is providing vitamin D for numerous scientific studies. To see their prices and for ordering, click the hyperlink below.

http://www.bio-tech-pharm.com/catalog.aspx?cat_id=2

As a gift to our readers for the New Year, Thorne publications have provided a free download to a basic paper aboutvitamin D. I wrote it earlier this year for educated lay people as well as health care practitioners. Please read this paper carefully, your family's well-being, even lives, may depend on you understanding it.

http://www.thorne.com/altmedrev/.fulltext/13/1/6.pdf

Seasons Greetings
John Cannell, MD
vitamindcouncil.org


Thank you for subscribing to the Vitamin D Newsletter from the Vitamin D Council. The Vitamin D Council is a non-profit trying to end the epidemic of vitamin D deficiency. Please reproduce this newsletter and post it on Internet sites. Remember, we are a non-profit and rely on donations to publish our newsletter and maintain our website. Send your tax-deductible contributions to:

The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422
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