About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spontaneous ICH diagnosis

Age ≥ 18 years

Within 96 hours of ICH

Premorbid Modified Rankin Scale of ≤2

Disqualifiers

Expected life expectancy of <1 year

Glasgow Coma Scale <9

Anticipated surgical evacuation of hematoma

Inability to participate in follow-up activity

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Vitamin D armActive comparator 1 intervention

Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

Day 14 of ICH

2

Incidence of hypercalcemia and vitamin D-related AE

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

Time frame

26 weeks

Secondary outcomes

1

Change in perihematomal edema from day 7 to 14

Absolute (perihematomal edema at day 14 - 7) and relative (absolute reduction/ perihematomal edema at day 14) changes of perihematomal edema will be calculated

Time frame

Day 14 of ICH

2

Modified Rankin Scale

Neurological recovery will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where 0 indicates no symptoms, 1-5 indicate increasing levels of neurological disability, and 6 indicates death.

Time frame

12 weeks

3

Modified Rankin Scale

Neurological recovery will be assessed using the Modified Rankin Scale (mRS), which ranges from 0 to 6, where 0 indicates no symptoms, 1-5 indicate increasing levels of neurological disability, and 6 indicates death.

Time frame

26 weeks

Vitamin D for Acute Intracerebral Hemorrhage

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts