Vitamin D for Acute Intracerebral Hemorrhage (VICToHR)

April 29, 2026 updated by: The University of Hong Kong

Vitamin D Treatment in IntraCerebal Hemorrhage To Enhance Hematoma Resolution (VICToHR): a Pilot Study

Intracerebral hemorrhage (ICH) is the most deadly and debilitating form of stroke. To date, effective treatment that could improve the functional outcome of ICH remained elusive. In a mice model of ICH, it was demonstrated that high dose Vitamin D (VitD) treatment enhanced hematoma resolution by promoting reparative macrophage differentiation and improved neurobehavioral performance in mice. Hence, this pilot study aimed to investigate the feasibility and safety of VitD treatment for ICH in human subjects.

VICToHR is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Participants will be randomized 1:1 to receive either VitD or standard care (control). The intervention group will receive VitD 4000 IU daily for 2 weeks, followed by 1000 IU daily for 24 weeks. The primary outcomes are the rate of hematoma resolution at 14 days and the incidence of hypercalcemia and VitD toxicity. Hematoma volume will be assessed by a neuroradiologist who is blinded to treatment allocation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intracerebral hemorrhage (ICH) is the most deadly and debilitating form of stroke. To date, effective treatment that could improve the functional outcome of ICH remains elusive. In ICH, the hematoma causes primary mass effect and neuronal damage, and inflammatory responses and elevated intracranial pressure drive secondary brain injuries. Though hematoma removal may alleviate brain injury, surgical evacuation is not indicated for most ICH patients due to significant complications and lack of functional benefit. An alternative approach is to exploit the endogenous mechanism of hematoma clearance, which provides a druggable target in treating ICH. Given the overwhelming burden of ICH in our aging population, a safe and accessible drug that could improve ICH outcomes is in dire need.

Long prescribed to maintain calcium balance and bone health, Vitamin D (VitD) supplement has also shown beneficial effects in preclinical models of brain diseases, including ischemic stroke and subarachnoid hemorrhage. Recently, we reported that a supraphysiological dose of VitD treatment improved neurobehavioral performance in young and middle-aged mice after ICH. In our study, VitD treatment significantly reduced hematoma volume by 41% on day three compared to the vehicle group while reducing perihematomal edema by 47%. We also demonstrated that VitD increased the macrophage number and elevated levels of CD36 and PPAR-γ in the brain, facilitating hematoma clearance. VitD also accelerated the differentiation of reparative macrophages from bone marrow-derived monocytes. This study is the first to address the therapeutic effects of VitD in an animal model after ICH.

Currently, data from clinical trials applying post-ICH VitD treatment and involving hematoma volume as primary outcomes are lacking. Based on the promising findings from our preclinical study, we plan to launch VICToHR trial to investigate whether VitD would confer therapeutic benefits in ICH patients. A supraphysiological VitD dose of 4000 IU/day per oral (PO) will be utilized as it is demonstrated to be safe and well tolerated. In this pilot study, we aim to examine the safety and feasibility of VitD treatment for ICH in human subjects.

VICTHoR trial will have 2 phases. The first phase of the study is a single-arm pilot intervention trial involving the recruitment of 10 patients who will be prescribed high doses of VitD. The aim of this phase is to evaluate the safety of VitD before moving on to the second phase of the trial. The second phase will be an open-label, parallel randomized controlled trial.

Consecutive ICH patients aged ≥ 18 years, admitted to Queen Mary Hospital (QMH), Hong Kong, and who fulfill the inclusion criteria (table 1), will be screened for recruitment. Eligible patients will be screened by experienced stroke neurologists (KCT and GKKL) or neurosurgeon (GKL).

During the first phase, written informed consent will be obtained from all study subjects. Ten consecutive patients recruited into VICToHR will be prescribed VitD. During the second phase, written informed consent will be obtained from all study subjects or next-of-kin. For patients with cognitive impairment who are deemed mentally incompetent, informed consent will be obtained from their next-of-kin (spouse, parent, or child) or legal guardian. Randomization will be according to a computer-generated sequence (https://www.sealedenvelope.com) in a 1:1 ratio to VitD or non-VitD (control) group. In VitD group, Daily 4000 IU of VitD will be given orally or via nasogastric tube for two weeks. Subjects are later maintained on a standard daily dose of 1000 IU of VitD for 24 weeks as the incidence of VitD deficiency is reported to be around 60% in stroke survivors. In control group, Subjects will be managed according to the stroke protocol of Queen Mary Hospital.

Study subjects will have clinical assessments, blood checking, and CT brain scan according to the schedule on Day 3, Day 7, Day 14, Day21 and Week 12, Week 26. Three interval CT scans of the brain will be performed for all patients. CT will be assessed for ICH location, volume, and perihematomal edema.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kay Cheong Teo, MBBS, MD
  • Phone Number: 852-22552368
  • Email: kcteo@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Kay Cheong Teo, MBBS, MD
          • Phone Number: 852-22552368
          • Email: kcteo@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Spontaneous ICH diagnosis
  • Age ≥ 18 years
  • Within 96 hours of ICH
  • Premorbid Modified Rankin Scale of ≤2
  • Supratentorial ICH
  • ICH volume ≥2 mL

Exclusion Criteria:

  • Expected life expectancy of <1 year
  • Glasgow Coma Scale <9
  • Anticipated surgical evacuation of hematoma
  • Inability to participate in follow-up activity
  • Hypercalcemia
  • Hyperphosphatemia
  • History of kidney stones
  • Bleeding tendency
  • Severe renal impairment
  • Severe liver impairment
  • Known contraindication or allergy to vitamin D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D arm
Vitamin D 4000 IU daily for 2 weeks followed by 1000 IU for 24 weeks
Drug: Vitamin D
Vitamin D 4000 IU daily for 2 weeks followed by 1000 IU daily for 24 weeks
No Intervention: Control arm
No vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypercalcemia and vitamin D-related AE
Time Frame: 26 weeks
Incidence of hypercalcemia, vitamin D toxicity or any AE deemed related to VitD.
26 weeks
Change in hematoma volume at day 14 compared to baseline volume
Time Frame: Day 14 of ICH
Absolute (Hematoma volume at day 14 - baseline) and Relative (Absolute hematoma resolution/ volume at baseline) changes in hematoma volume will be assessed.
Day 14 of ICH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale
Time Frame: 12 weeks
Neurological recovery will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where 0 indicates no symptoms, 1-5 indicate increasing levels of neurological disability, and 6 indicates death.
12 weeks
Modified Rankin Scale
Time Frame: 26 weeks
Neurological recovery will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where 0 indicates no symptoms, 1-5 indicate increasing levels of neurological disability, and 6 indicates death.
26 weeks
Change in perihematomal edema from day 7 to 14
Time Frame: Day 14 of ICH
Absolute (perihematomal edema at day 14 - 7) and relative (absolute reduction/ perihematomal edema at day 14) changes of perihematomal edema will be calculated
Day 14 of ICH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Kay Cheong Teo, MBBS, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-002
  • 21220061 (Other Identifier: Health and Medical Research Fund, Hong Kong SAR, China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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