Patients with cystic fibrosis (CF) complicated by allergic bronchopulmonary aspergillosis (ABPA) are vitamin D deficient and
treatment with 1,25 (OH)
vitamin D
of CD4+ cells from CF patients with ABPA decreases
(Af)-induced Th2 responses. This Phase I clinical trial investigated the safety and effectiveness of daily vitamin D
supplementation in CF patients with ABPA to reduce allergic responses and ABPA symptoms, and increase serum vitamin D levels.
Seven patients ages 12 years and older with a clinical diagnosis of CF and ABPA with current evidence of Af sensitization received 4000 IU vitamin D
(cholecalciferol) daily for 24 weeks. The primary outcome of the study was safety followed by the
induced IL-13 response in CD4+ T cells to test the hypothesis that vitamin D supplementation is safe and reduces
induced IL-13 responses in CD4+ T cells. Secondary outcomes included total IgE,
-specific IgE, vitamin D levels, FEV
, urinary calcium/creatinine ratio, and cytokine production by
-stimulated peripheral blood T cells.
Six months of vitamin D
supplementation resulted in significant increases in serum 25-(OH) vitamin D level, and the treatment was well tolerated without evidence of vitamin D toxicity or hypercalcemia. There were no serious adverse events. Daily vitamin D supplementation led to significantly decreased
induced IL-13 responses between the baseline visit and that at 24 weeks (p = 0.04).
-specific IgE level was also significantly decreased after 8 (p = 0.035) and 24 weeks of daily vitamin D supplementation (p = 0.04).
4000 IU vitamin D
daily over a 24-week period is well tolerated in CF patients with a history ABPA and current evidence of Th2 immunity to Af. . Daily vitamin D supplementation was associated with reduced
induced IL-13 responses from peripheral. . CD4+ T cells and
-specific IgE levels, as well as increased serum vitamin D levels. This treatment was well tolerated and the study supports further investigation of the use of vitamin D supplementation in Th2 mediated diseases.
This trial was registered at www.clinicaltrials.gov as NCT01222273....

Vitamin D supplementation decreases Aspergillus fumigatus specific Th2 responses in CF patients with aspergillus sensitization: a phase one open-label study

10.1186/s40733-015-0003-5