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Not Yet RecruitingNCT07458815

Vitamin D for Acute Intracerebral Hemorrhage

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGVitamin DVitamin D 4000 IU daily for 2 weeks followed by 1000 IU daily for 24 weeks

Timeline

Start date
2026-03-01
Primary completion
2027-08-31
Completion
2028-02-28
First posted
2026-03-09
Last updated
2026-03-09

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07458815. Inclusion in this directory is not an endorsement.

Vitamin D for Acute Intracerebral Hemorrhage (NCT07458815) · Clinical Trials Directory