DIRECT-MS sponsors a vitamin D trial

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DIRECT-MS sponsors a vitamin D trial

Postby Nick » Fri Sep 22, 2006 3:03 pm

A Dose/Safety Study of Vitamin D for Persons with Multiple Sclerosis

Introduction – Beginning in 2000, Direct-MS has strongly advocated the use of adequate vitamin D supplementation for the prevention and treatment of multiple sclerosis. Since that time we have also actively promoted the need for clinical research to test the effectiveness of vitamin D for preventing and treating MS. Before clinical trials to test the efficacy of vitamin D for MS can be done, it is necessary to determine the optimal dosage of vitamin D to use in such a trial. Direct-MS chose to fund this preliminary “Dose/Safety” study for vitamin D to ensure that the necessary clinical research on the efficacy of vitamin D for MS happens as soon as possible.

Leaders – The chief investigator of the clinical research is Dr Paul O’Connor, Clinical and Research Neurologist, Chief, Division of Neurology and Director of the MS Centre at St Michael’s Hospital in Toronto. Dr O’Connor has assembled a large and impressive team of researchers for this trial. They include Dr Jodie Burton, Co-investigator, MS Clinical Fellow, St. Michael’s Hospital, University of Toronto; Dr Melanie Ursell, Co-investigator, Staff, Division of Neurology, St. Michael’s Hospital; Dr Reinhold Vieth, Co-investigator. Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto; Samantha Kimball, Co-investigator. Master of Science Student, Department of Nutritional Sciences, University of Toronto; Dr. Louise Thibault Professor, School of Dietetics and Human Nutrition, McGill University, Montreal; Sally Kilborn, Master of Science Student, School of Dietetics and Human Nutrition, McGill University; Dr. H. Michael Dosch, Co-investigator. Professor of Immunology, University of Toronto and the Hospital for Sick Children, Toronto; Dr Amit Bar-Or, Co-investigator. Department of Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, Montreal; Dr Cheryl D’Souza, Centre for Research in Neurodegenerative Diseases, University of Toronto. .


Ethics – The study has been approved by the Ethics Boards of St Michael’s Hospital and McGill University.

Goals
– The main goal of the study is to determine the optimal dose of vitamin D to use in a subsequent clinical trial which will test the efficacy of vitamin D for affecting disease activity in MS. Such an optimal dose will be the maximum dose which is well tolerated without any adverse side effects and which also has a significant effect on immune activity.
A second objective is to determine if there are any positive effects of higher doses of vitamin D3 on bone health in people with MS.
A third objective is to examine the relationship between diet and MS especially vitamin D intake from food sources.
A fourth objective is to examine the effect of vitamin D on mood and feelings of well-being of the participants.

Methods – The study will involve 30 participants, all of whom have MS (RRMS, SPMS or PPMS) and will last one year. Each participant will be given an increasing dose of vitamin D3 starting at 28,000 IU per week (4000 IU/d). The dose of vitamin D3 will be gradually increased every 2 to 6 weeks to the highest dose of 280,000 IU per week (40,000 IU per day). After the highest dose is taken for 6 weeks, the dose of vitamin D3 will be lowered to a maintenance dose of 70,000 IU per week (10,000 IU per day) that will be taken for 12 weeks. The dose of vitamin D3 will then be lowered again to 28,000 IU per week (4000 IU per day) taken for another 8 weeks. 1200 mg of calcium will be taken daily during the entire study.

Blood and urine samples will be obtained every month and analyzed to determine if any anomalous calcium or creatinine/calcium ratios are present in any of the participants. The blood samples will also be analyzed for immunological markers of inflammation and blood brain barrier integrity (cytokine profiles, lymphocyte response measures and matrix metalloproteinases) and the proportion of change in bone turnover markers. Measures of well being will be assessed using the Hospital Anxiety and Depression Scale questionnaire.

To examine dietary habits and amounts of nutrients participants get in the diet, particularly vitamin D, they will be asked to complete a “Food Frequency Questionnaire”. In addition, a “24-hour recall” food questionnaire will be given.

Results – The blood tests will determine if high doses of vitamin D3 have any adverse effects on calcium levels in the body. Such adverse effects include the elevation of serum calcium levels above normalized ranges (range 2.1-2.6 millimoles per liter) or urinary calcium:creatinine ratios above 1.0. The measurement of immunological markers will allow the determination of the effects of the various doses of vitamin D3 on immune activity. These two data sets will allow an optimal dose of vitamin D to be determined. Such a dose will be used in subsequent clinical trials for MS and possibly other diseases related to vitamin D deficiency (e.g. prostate cancer).

The other studies mentioned above will provide insight into the value of higher doses of vitamin D for preventing and treating osteoporosis and for treating depression.

Discussion – This clinical trial is basically a “Phase I” trial meaning it is designed to determine the metabolism and pharmacologic action of vitamin D3 in humans, the side effects associated with increasing doses, and evidence of effectiveness for treating immune reactions related to MS disease activity.

Such a trial must be done before any proper clinical trial on the effectiveness of optimal doses of vitamin D for treating MS can be initiated.

Cheers
Nick
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Postby sh8un » Fri Sep 22, 2006 4:22 pm

Hi Nick
Glad you are here. I have been looking at Direct-MS and love it. I am glad that we are now researching diets and vit.
Thanx for sharing,
Nn
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Postby LisaBee » Fri Sep 22, 2006 6:54 pm

Nick,

I think the trial is actually further along - Phase 1 has been completed and they are now at Phase II or at least somewhere between Phase I and Phase II. I think I posted the June abstract under dignan's clinical trial list to show the work was still active and findings to date. They did not see any response on MS endpoints during the Phase I, but I don't think that was expected over the time frame and dosage regimen - they were mostly walking up the Vitamin D dosage and monitoring the subjects for adverse effects related to Vitamin D, as your post noted. The work will be important, not only for MS but for other research relating to optimization and safety of vitamin D dosage.
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Postby Nick » Wed Sep 27, 2006 1:45 pm

LisaBee

You're absolutely correct, the first part of the trial has been completed. We're funding the long term segment of the study and hopefully we will detect a significant effect on immune activity.

I agree that dispelling the misconceptions about how much vitamin D it takes to be toxic can be applied to numerous diseases and conditions.

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Nick
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