Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07458815

Vitamin D for Acute Intracerebral Hemorrhage

Led by The University of Hong Kong · Updated on 2026-05-06

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Vitamin D for Acute Intracerebral Hemorrhage

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of spontaneous intracerebral hemorrhage (ICH)
  • Age 18 years or older
  • Within 96 hours of ICH onset
  • Premorbid Modified Rankin Scale score of 2 or less
  • Supratentorial (above the tentorium) ICH location
  • Hematoma volume of 2 mL or more
Not Eligible

You will not qualify if you...

  • Expected life expectancy less than 1 year
  • Glasgow Coma Scale score less than 9
  • Planned surgical removal of hematoma
  • Unable to participate in follow-up activities
  • Hypercalcemia (high blood calcium levels)
  • Hyperphosphatemia (high blood phosphate levels)
  • History of kidney stones
  • Bleeding tendency
  • Severe kidney impairment
  • Severe liver impairment
  • Known allergy or contraindication to vitamin D

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

K

Kay Cheong Teo, MBBS, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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