Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT01426256
Eligibility Criteria:
Inclusion Criteria:
* Adult and adolescent CF patients
* age \>16 years
* admitted to the inpatient hospital setting for a pulmonary exacerbation of cystic fibrosis
* enrolled within 72 hours of admission
* able to tolerate oral medications
* expected to survive hospitalization
Exclusion Criteria:
* Inability to obtain or declined informed consent from the subject and/or legally authorized representative
* History of serum 25(OH)D \>55 ng/mL in the past 12 months
* History of serum 25(OH)D \<10 ng/mL in the past 12 months
* Current intake of more than 2,000 IU of vitamin D
* intake of 2,000 IU of vitamin D or its equivalent weekly dose (14,000 IU) for more than 1 week at any time within the past 60 days or intake of greater than vitamin D 10,000 IU once at anytime in the past 60 days
* Pregnancy or plans to become pregnant during the course of the study (12 months)
* History of disorders associated with hypercalcemia including parathyroid disease
* Current hypercalcemia (albumin-corrected serum calcium \>10.8 mg/dL or ionized calcium \>5.2 mg/dL)
* History of nephrolithiasis
* Chronic kidney disease worse than stage III (\<60 ml/min)
* Oral or intravenous glucocorticoid use currently or in the past month
* History of lung transplantation or awaiting lung transplant
* patient in hospice care
* FEV1% predicted \<20%
* Current significant hepatic dysfunction total bilirubin \> 2.5 mg/dL with direct bilirubin \> 1.0 mg/dL
* Current use of cytotoxic or immunosuppressive drugs
* History of AIDS
* History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
* Previous enrollment in the study
* Current enrollment in another intervention trial
* Too ill to participate in study based on investigator's or study team's opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01426256
Study Brief:
Protocol Section:
NCT01426256