Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT07269457
Description:
The following de-identified individual participant data (IPD) will be shared:
Baseline demographics (age, sex, socioeconomic status, education level). Clinical characteristics at admission (Glasgow Coma Scale score, time from injury to presentation, comorbidities).
Laboratory results (serum 25(OH)D levels, calcium, creatinine, CRP, ESR, and other inflammatory markers such as SIRI, SII, PLR, NLR).
Intervention assignment (treatment arm) and dosing adherence. Neurological outcome measures (Glasgow Outcome Scale-Extended \[GOS-E\], Modified Rankin Scale \[mRS\]) at Weeks 4, 12, and 24.
Clinical outcomes (length of hospital stay, complications, 28-day mortality, 12-week mortality).
Adverse events and serious adverse events, including severity and relatedness to intervention.
Cost-related outcomes (hospitalization cost, laboratory investigations, and other direct medical costs).
Study:
NCT07269457
Study Brief:
Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)