Vitamin D treatment after intracerebral hemorrhage
Vitamin D Treatment in IntraCerebal Hemorrhage To Enhance Hematoma Resolution (VICToHR): a Pilot Study
This will try giving higher-dose vitamin D to adults within 96 hours of an intracerebral hemorrhage to see if it helps clear the bleed faster and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07458815 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, blinded-endpoint (PROBE) pilot comparing vitamin D supplementation versus standard care in adults with spontaneous supratentorial intracerebral hemorrhage. Participants are randomized 1:1 to receive vitamin D 4000 IU daily for two weeks then 1000 IU daily for 24 weeks, or standard care, with neuroradiologists blinded for hematoma measurements. The primary outcomes are the rate of hematoma resolution at 14 days and the incidence of hypercalcemia and vitamin D toxicity; hematoma volume change is centrally read by a blinded rater. Key eligibility includes age ≥18, presentation within 96 hours of ICH, premorbid mRS ≤2, and ICH volume ≥2 mL, while patients with severe organ dysfunction, hypercalcemia, or anticipated surgical evacuation are excluded.
Who should consider this trial
Good fit: Adults with spontaneous supratentorial ICH who present within 96 hours, have premorbid mRS ≤2, an ICH volume ≥2 mL, and no contraindications to vitamin D are ideal candidates.
Not a fit: Patients with severe coma (GCS <9), those expected to need surgical hematoma evacuation, with hypercalcemia, severe renal or liver impairment, or who present late (>96 hours) are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could speed hematoma clearance and reduce secondary brain injury using an inexpensive, widely available supplement.
How similar studies have performed: Preclinical mouse studies demonstrated improved hematoma clearance and function with high-dose vitamin D, but human data for ICH are novel and limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spontaneous ICH diagnosis * Age ≥ 18 years * Within 96 hours of ICH * Premorbid Modified Rankin Scale of ≤2 * Supratentorial ICH * ICH volume ≥2 mL Exclusion Criteria: * 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
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kay Cheong Teo, MBBS, MD — The University of Hong Kong
- Study coordinator: Kay Cheong Teo, MBBS, MD
- Email: kcteo@hku.hk
- Phone: 852-22552368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.