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Table 1 Inclusion and exclusion criteria for vitamin D supplementation trial

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

Inclusion criteria Exclusion criteria
≥12 years male or female Systemic corticosteroids (1 mg/kg if <20 kg or >20 mg of prednisone per day)
Confirmed CF diagnosis
1. One or more clinical features consistent with CF phenotype AND (2 or 3) Investigational drug use within 30 days of screening
2. Positive sweat chloride >60 mEq/L Laboratory abnormalities at screening
3. Two identifiable mutations consistent with CF Serum calcium > 11 mg/dL
Written informed consent (or assent) 25 (OH) D > 50 ng/mL at screening
Clinically stable at enrollment as assessed by site investigator Creatinine ≥ 1.5 or estimated GFR < 60 by Cockcroft-Gault or MDRD equation
Past or present respiratory culture positive for Aspergillus fumigatus LFT ≥ 3x ULN
IgE ≥ 250 and/or presence of Class II or higher Aspergillus specific IgE on enrollment History or transplantation or currently on transplant list
Ability to comply with medication use, study visits and study procedures as judged by site investigator Positive serum pregnancy test at screening
Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in study
Presence of a condition or abnormality that would compromise safety of subject or quality of data
Diagnosis of HIV and a CD4+ T cell count < 500 cells/mL or active hepatitis C infection
Undergoing therapy for non-tuberculosis mycobacterial infection