Safety Data in Patients with Autoimmune Diseases during Treatment with High Doses of Vitamin D3 According to the "Coimbra Protocol"

Background: In 2013, the group of Cicero Coimbra, Brazil, reported the clinical efficacy of high doses of vitamin D3 in patients suffering from autoimmune skin disorders ("Coimbra protocol", CP). However, hypercalcemia and the subsequent impaired renal function may be major concerns raised against this protocol. Methods: We report for the first time for a broad spectrum of autoimmune diseases in 319 patients (mean age (+/- SD) 43.3 +/- 14.6 years, 65.5% female, 34.5% male) safety data for high doses of orally applied vitamin D3 (treatment period: up to 3.5 years) accompanied by a strict low-calcium diet and regular daily fluid intake of at least 2.5 L. Results: Mean vitamin D3 dose was 35,291 +/- 21,791 IU per day. The measurement of more than 6100 single relevant laboratory parameters showed all mean values (+/- SD) within the normal range for total serum calcium (2.4 +/- 0.1 mmol/L), serum creatinine (0.8 +/- 0.2 mg/dL), serum creatinine associated estimated GFR (92.5 +/- 17.3 mL/min), serum cystatin C (0.88 +/- 0.19 mg/L), serum TSH (1.8 +/- 1 mIU/L), and for 24 h urinary calcium secretion (6.9 +/- 3.3 mmol/24 h). We found a very weak relationship between the dosage of oral vitamin D3 and the subsequent calcium levels, both in serum and in urinary excretion over 24 h, respectively. Conclusions: Our data show the reliable safety of the CP in autoimmune patients under appropriate supervision by experienced physicians.