RecruitingNot ApplicableNCT07458815

Vitamin D for Acute Intracerebral Hemorrhage

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


Sponsor

The University of Hong Kong

Enrollment

40 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

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

Exclusion Criteria11

  • 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

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Interventions

DRUGVitamin D

Vitamin D 4000 IU daily for 2 weeks followed by 1000 IU daily for 24 weeks


Locations(1)

The University of Hong Kong

Hong Kong, Hong Kong

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NCT07458815


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