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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT07269457
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 65 years
* Diagnosed with mild-to-moderate TBI defined by GCS 9-15
* Presenting within 24 hours of head injury
* Willing and able to provide informed consent or have a legal representative provide consent
* Confirmed vitamin D-deficient status (\<30 ng/mL) for randomization into treatment arms OR Vitamin D-sufficient (≥30 ng/mL) to be eligible for inclusion in the observational control arm.
Exclusion Criteria:
* Severe TBI (GCS ≤8)
* Prior use of vitamin D supplements within the past month
* History of hypercalcemia or hyperparathyroidism
* Pregnancy or lactation
* Use of immunosuppressive agents (e.g., corticosteroids, cytotoxic drugs)
* Chronic liver disease
* End-stage renal disease
* Any terminal illness or comorbidity with expected survival \<3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07269457
Study Brief:
Protocol Section:
NCT07269457