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Posted: Mon May 05, 2008 11:39 am Post subject: Results of Direct-MS' sponsored trial on vitamin D safety
G'day people. The results are in from Direct-MS'ssponsored trial outlined here.
A Phase I/II Dose Escalation Trial of Oral Vitamin D3 with Calcium Supplementation in Patients with Multiple Sclerosis
Jodie M. Burton, Samantha Kimball, Reinhold Vieth, Amit Bar-Or, Montreal, QC, Canada, Hans-Michael Dosch, Louise Thibault, Sally Kilborn, Ste. Anne de Bellevue, QC, Canada, Cheryl D'Souza, Melanie Ursell, Paul O'Connor, Toronto, ON, Canada
OBJECTIVE: The main objective of the trial was to determine the safety of high-dose vitamin D3 (VD3) in Multiple Sclerosis (MS).
BACKGROUND: A clear inverse relationship exists between VD3 status and the probability of developing MS, likely through VD3 s immunoregulatory effects. If VD3 plays a role in MS development, it may also play a beneficial role after MS has developed, but a safe, effective dose must be established.
DESIGN/METHODS: This prospective controlled phase I/II 52-week trial matched clinically definite MS patients for age, gender, MS duration, EDSS, disease modifying drugs, and MS subtype. Patients were randomized to treatment or control groups. Treatment patients started at VD3 doses of 4,000 IU/d and escalated over 28 weeks to 40,000 IU/d. They were then maintained on 10,000 IU/d for 12 weeks, 4,000 IU/d for 8 weeks and a 4-week wash out. Calcium was given throughout the trial. The primary endpoint was mean change in serum calcium concentration in treatment patients over the year. Secondary endpoints included change in 25(OH)D, parathyroid hormone and urinary calcium/creatinine. EDSS and relapse rate were also evaluated, as were cytokine profiles, lymphocyte assays and matrix metalloproteinases across VD3 doses and between treatment and control groups.
RESULTS: Fifty patients were enrolled, with mean age 40.5y (21-54), EDSS 1.25 (0-6.5), and baseline 25(OH)D of 78nmol/L ( 27). Groups were balanced at baseline on all relevant parameters. Two patients dropped out, one before screening and one (treatment) at visit 3 for reasons unknown. With a mean serum 25(OH)D of 409nmol/L ( 152) at 40,000 IU/d, no hypercalcemia occurred nor did persistent hypercalciuria, with no significant differences in serum calcium values between the two groups. A trend of greater reduction in annualized relapse rate favoured treatment patients. Immunological results will be presented.
CONCLUSIONS/RELEVANCE: High-dose VD3 appears to be safe and tolerable in MS patients. Supported by: Direct-MS.
Category - MS and Related Diseases
SubCategory - Clinical Science
This following is another study conducted by some of the same researchers as the above trial. It was NOT funded by Direct-MS. Sorry for the confusion.
BACKGROUND: Vitamin D3 may have therapeutic potential in several diseases, including multiple sclerosis. High doses of vitamin D(3) may be required for therapeutic efficacy, and yet tolerability--in the present context, defined as the serum concentration of 25-hydroxyvitamin D [25(OH)D] that does not cause hypercalcemia--remains poorly characterized. OBJECTIVE: The objective of the study was to characterize the calcemic response to specific serum 25(OH)D concentrations.
DESIGN: In a 28-wk protocol, 12 patients in an active phase of multiple sclerosis were given 1200 mg elemental Ca/d along with progressively increasing doses of vitamin D3: from 700 to 7000 microg/wk (from 28,000 to 280,000 IU/wk). RESULTS: Mean (+/- SD) serum concentrations of 25(OH)D initially were 78 +/- 35 nmol/L and rose to 386 +/- 157 nmol/L (P < 0.001). Serum calcium concentrations and the urinary ratio of calcium to creatinine neither increased in mean values nor exceeded reference values for any participant (2.1-2.6 mmol/L and <1.0, respectively). Liver enzymes, serum creatinine, electrolytes, serum protein, and parathyroid hormone did not change according to Bonferroni repeated-measures statistics, although parathyroid hormone did decline significantly according to the paired t test. Disease progression and activity were not affected, but the number of gadolinium-enhancing lesions per patient (assessed with a nuclear magnetic brain scan) decreased from the initial mean of 1.75 to the end-of-study mean of 0.83 (P = 0.03).
CONCLUSIONS: Patients' serum 25(OH)D concentrations reached twice the top of the physiologic range without eliciting hypercalcemia or hypercalciuria. The data support the feasibility of pharmacologic doses of vitamin D3 for clinical research, and they provide objective evidence that vitamin D intake beyond the current upper limit is safe by a large margin.
PMID: 17823429 [PubMed - indexed for MEDLINE]
As the abstact states, the subjects were initally given 4,000 IU/d and at trial end, 40,000 IU/d. For optimal immunoregulation as suggested here and here, Direct-MS advocates taking 4,000 IU/d.
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