Table 1 Inclusion and exclusion criteria for vitamin D supplementation trial
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 |