Vitamin D for Acute Intracerebral Hemorrhage

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.

Timeline

Start

2026-03-01

Primary completion

2027-08-31

Completion

2028-02-28

Publications

• Background Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.
• Background Teo KC, Fong SM, Leung WCY, Leung IYH, Wong YK, Choi OMY, Yam KK, Lo RCN, Cheung RTF, Ho SL, Tsang ACO, Leung GKK, Chan KH, Lau KK. Location-Specific Hematoma Volume Cutoff and Clinical Outcomes in Intracerebral Hemorrhage. Stroke. 2023 Jun;54(6):1548-1557. doi: 10.1161/STROKEAHA.122.041246. Epub 2023 May 22.
• Background Liu J, Li N, Zhu Z, Kiang KM, Ng ACK, Dong CM, Leung GK. Vitamin D Enhances Hematoma Clearance and Neurologic Recovery in Intracerebral Hemorrhage. Stroke. 2022 Jun;53(6):2058-2068. doi: 10.1161/STROKEAHA.121.037769. Epub 2022 May 6.

Drugs

Indications