About this trial
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 criteria
Qualifiers
Spontaneous ICH diagnosis
Age ≥ 18 years
Within 96 hours of ICH
Premorbid Modified Rankin Scale of ≤2
Disqualifiers
Expected life expectancy of <1 year
Glasgow Coma Scale <9
Anticipated surgical evacuation of hematoma
Inability to participate in follow-up activity
Trial design
Treatments tested in this trial
- Vitamin D
Treatment groups
Locations
1Sponsors and collaborators
The University of Hong Kong
Lead sponsor