Vitamin D for Acute Intracerebral Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe University of Hong Kong

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

40 Participants
are divided into 2 treatment groups

Locations

1
The University of Hong Kong Hong Kong Hong Kong

Sponsors and collaborators

The University of Hong Kong

Lead sponsor