Vitamin D3 in Mild-to-Moderate Traumatic Brain Injury

Vitamin D3 for Mild-to-Moderate Traumatic Brain Injury (VIMOT Trial): A Phase II, Four-Arm, Randomized, Quadruple-Blinded, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202512562303079

Enrollment

240

Registered

2025-12-02

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

Placebo Group

High Dose Vitamin D3

Standard Dose Vitamin D3

Low Dose Vitamin D3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 18–65 years Diagnosed with mild-to-moderate TBI (Glasgow Coma Scale [GCS] 9–15) Presentation within 24 hours of injury Willing and able to provide informed consent (self or proxy) Serum 25(OH)D < 30 ng/mL (for randomized arms) =30 ng/mL (for vitamin D–sufficient control arms)

Exclusion criteria

Exclusion criteria: Severe TBI (GCS =8) Pre-existing hypercalcemia, renal disease, or hepatic failure Current vitamin D supplementation Pregnancy or lactation Active malignancy, immunosuppression, or chronic corticosteroid therapy

Design outcomes

Primary

Measure	Time frame
Change in inflammatory biomarkers CRP	—

Secondary

Measure	Time frame
Change in inflammatory biomarkers ESR, SIRI, SII, PLR, NLR;Neurological functional recovery assessed by Glasgow Outcome Scale–Extended (GOS-E);Neurological functional recovery assessed by Modified Rankin Scale (mRS)	—

Countries

Nigeria

Contacts

Public ContactOlokunbola Sunday

Secretay LASUTH

research.lasuth@gmail.com+2347039661906

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026