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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT01372995
Eligibility Criteria:
Inclusion Criteria:
* Receiving care in an intensive care unit (ICU)
* Age greater than 18 years
* Expected to require mechanical ventilation for at least 72 hours after entry
* Expected to survive and remain in the ICU for at least 96 hours after study entry
* To enable delivery of study drug, the subject has enteral access in place and is deemed able to tolerate enteral drug administration
Exclusion Criteria:
* Inability to obtain or declined informed consent from the subject and/or legally authorized representative
* Pregnancy
* Ongoing shock
* Current hypercalcemia (albumin-corrected serum calcium \> 10.8 mg/dL or ionized calcium \> 5.2 mg/dL)
* History of therapy with high-dose vitamin D to treat vitamin D deficiency within previous 6 months
* History of disorders associated with hypercalcemia; history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis\]
* Chronic renal dysfunction requiring chronic dialysis
* Known history of cirrhosis
* History of AIDS
* The patient has received any investigational drug within 60 days prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01372995
Study Brief:
Protocol Section:
NCT01372995