Vitamin D for Acute Intracerebral Hemorrhage

NCT07458815 | Recruiting

• 2 other identifiers: UW 24-00221220061
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Vitamin D

Outcome Measures

Primary Outcomes (2)

• Change in hematoma volume at day 14 compared to baseline volume

  Absolute (Hematoma volume at day 14 - baseline) and Relative (Absolute hematoma resolution/ volume at baseline) changes in hematoma volume will be assessed.

  Day 14 of ICH

• Incidence of hypercalcemia and vitamin D-related AE

  Incidence of hypercalcemia, vitamin D toxicity or any AE deemed related to VitD.

  26 weeks

Secondary Outcomes (3)

• Change in perihematomal edema from day 7 to 14

  Day 14 of ICH

• Modified Rankin Scale

  12 weeks

• Modified Rankin Scale

  26 weeks

Study Arms (2)

Vitamin D arm

ACTIVE COMPARATOR

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

Drug: Vitamin D

Control arm

NO INTERVENTION

No vitamin D

Interventions

Vitamin D DRUG

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

Vitamin D arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

• 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.

  PMID: 35579034 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.

  PMID: 37216445 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.

  PMID: 35514286 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kay Cheong Teo, MBBS, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kay Cheong Teo, MBBS, MD

CONTACT

852-22552368; kcteo@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Hematoma volume will be assessed by a neuroradiologist who is blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: VICToHR is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Participants will be randomized 1:1 to receive either vitamin D or standard care (control). The intervention group will receive vitamin D 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 vitamin D toxicity.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-02

Locations

HK (1)