M. Soilu-Hänninen, J. Åivo, M. Färkkilä, T. Sarasoja, L. Herrala, I. Keskinarkaus, B.-M. Lindström, I. Elovaara ( Finland)
Background: Several studies have suggested that vitamin D status may influence disease activity in MS. In small unblinded studies vitamin D compounds have reduced MS relapse rate and number of brain MRI lesions, but randomised, placebo-controlled trials with vitamin D in MS have not been published.
Goals of the study: We present a randomised, placebo-controlled trial with once-weekly colecalciferol or identically appearing placebo capsules containing 20000 IU (500 micrograms) of vitamin D3/week. The primary efficacy variables are MRI T2 BOD and T1 enhancing lesion volume and the proportion of patients with PTH<20 ng/L and S-(OH)D>85 nmol/L. The primary efficacy variables will be analyzed using logistic regression with the aid of the SAS-program.
Patients and Methods: 70 Finnish RR-MS-patients from 7 centers having used at least one month of IFN-beta-1b s.c. were randomised. The mean age of the patients was 37.1 years (range 22-53) and mean EDSS 1.8 (range 0-5). The patients were randomised 1:1 to receive either colecalciferol or identically appearing placebo capsules for 12 months. Laboratory investigations included serum 25-hydroxyvitamin D, MxA, PTH (parathyroid hormone) at baseline and 6 and 12 months. Clinical assessments included adverse events, relapses, EDSS, timed 25-foot walk test and timed 10-foot tandem walk test. Dietary intake of vitamin D and calcium was assessed using food diaries. Brain MRI was done at baseline and 12 months and analysed in the Neuroimaging Research Unit, Milan, Italy.
Baseline results: The mean serum level of 25-hydroxyvitamin D at baseline was 54.4 nmol/l (range 16-82) and mean serum level of PTH 42.1 ng/L (range 1-77). The mean vitamin D intake from food was 2.5 microg/day (range 0.2-9.3, RDI 7.5 microg/day) and the mean calcium intake from food was 1002 mg/day (range 199-2686 mg, RDI 800 mg/day). Mean T2 BOD at baseline was 9338 mm^2 (range 204-44053). 18% of patients had GD enhancing lesions at baseline. The mean volume of the enhancing lesions was 326 mm^2 (range 67-1104). Pearson’s correlation coefficient for MRI T2 BOD vs S-OH(D)2 was r=-0.01 (P=0.92) and for GDBOD vs S(OH)D2 r=-0.09 (P=0.48).
Conclusions: Finnish MS-patients get insufficient amount of vitamin D but enough calcium from diet. There is some correlation with the volume of brain MRI enhancing lesions with the serum levels of 25-hydroxyvitamin D, but the correlation is not linear.
“It is clear that most northern Europeans can be vitamin deficient, whether this is too late to supplement I wonder, as migration studies implicate that the enviromental impact occurrs early in MS.”