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Background: Vitamin D₃ may have therapeutic potential in several diseases, including multiple sclerosis. High doses of vitamin D₃ 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 μg/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 …