NCT03482843

Brief Summary

Vitamin D has been promoted to vascular regeneration in non-cerebral arteries because of its anti-inflammatory properties. Cerebral vasospasm (CVS) as the most feared complication after subarachnoid hemorrhage (SAH), correlated with higher mortality and poor outcome, is the result of a multifactorial mechanism with inflammation as one of the main role players. The investigators therefore hypothesized that vitamin D attenuates cerebral vasospasm and increases the chance for favorable outcome after SAH.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 18, 2018

Last Update Submit

March 28, 2018

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • clinical outcome at discharge

    modified Rankin scale (for measuring the dependence in daily activity. Range 0 (no symptoms) to 6 (dead)

    2 to 4 weeks after SAH

Secondary Outcomes (1)

  • clinical outcome 6 months after SAH

    6 months after SAH

Study Arms (2)

Vitamin D Deficiency

25-Vitamin D level \<25 ng/ml

Sufficient Vitamin D Level

25-Vitamin D Level \>=25-70 ng/ml

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All admitted SAH patients over 18 years of age.

You may qualify if:

  • Admitted patients suffering from SAH over 18 years of age with consent form.

You may not qualify if:

  • Admitted patients suffering from SAH younger than 18 years of age.
  • SAH patients without consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Hospital

Frankfurt am Main, Germany

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Juergen Konczalla, Prof.

    Goethe University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 29, 2018

Study Start

February 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2019

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

DE(1)