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Could a cheap vitamin pill boost brain healing after head injury?

NCT ID NCT07269457

Disease control Sponsor: Lagos State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether vitamin D3 supplements can reduce inflammation and improve recovery in adults with mild-to-moderate traumatic brain injury. Researchers will give different doses of vitamin D3 or a placebo to 240 participants and track their blood markers and neurological function for 24 weeks. The goal is to see if this safe, low-cost supplement can become a standard treatment for brain injury recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin D3 (cholecalciferol)
What this could lead to
If it works, this could point toward a simple, low-cost way to help the brain heal after a head injury, especially in places with limited resources.
What could go wrong
This is an early phase 2 trial with only 240 people, so results may not apply to everyone. Vitamin D is generally safe, but high doses can cause side effects like kidney stones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Neuroinflammatory Diseases neuronitis traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroinflammation Traumatic brain injury (TBI) patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lagos State University Teaching Hospital

    RECRUITING

    Lagos, Nigeria

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