Ischemic StrokeIVASTONCT03819452
Impact of Vitamin D on Acute Ischemic Stroke Prognosis
An observational study of Ischemic Stroke, run by Abha International Private Hospital at 2 sites in 2 countries.
Trial summary
This is a registry for all patients admitted to hospital settings with Ischemic stroke in Mansoura University Hospital. The registry will capture patients' data, investigations and vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Vitamin D Level
- How many people
- 59 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2018to 25 Jan 2019
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending to hospital settings diagnosed with ischemic stroke are investigated to have low level of vitamin D
Who may be able to join
- Newly diagnosed ischemic stroke not older than 48 hours
Who cannot join
- Ischemic stroke due to accidents or any trauma
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a registry for all patients admitted to hospital settings with Ischemic stroke in Mansoura University Hospital. The registry will capture patients' data, investigations and vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE
- Conditions
- Ischemic Stroke
- Being tested
- Vitamin D Level
- Keywords
- vitamin D, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D LevelDiagnostic test
Vitamin D level is measured upon the presentation of the case with ischemic stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Vitamin D level and the Incidence of Ischemic Stroke
Correlation Analyses between vitamin D and ischemic stroke will be applies
Measured: On admission
Secondary outcomes (1)
impact of vitamin D on ischemic stroke in relationship with gender
subgroup analyses per gender will be applied to check the difference of vitamin D
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Aug 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Abha International Private Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
- Investigators
- Mohamed FLeifel, MD PhD, Study director, Abha International Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819452
- Sponsor's protocol ID
- Fleifel002
- Acronym
- IVASTO
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of study participants will be kept confidential and no intention for distribution.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D on Acute Ischemic Stroke Prognosis
- ClinicalTrials.gov ID
- NCT03819452
- Acronym / sponsor ID
- IVASTO / Fleifel002
- Conditions
- Ischemic Stroke
- Keywords
- vitamin D, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Abha International Private HospitalUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a registry for all patients admitted to hospital settings with Ischemic stroke in Mansoura University Hospital. The registry will capture patients' data, investigations and vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending to hospital settings diagnosed with ischemic stroke are investigated to have low level of vitamin D
Key inclusion criteria (1 listed)
- Newly diagnosed ischemic stroke not older than 48 hours
Key exclusion criteria (1 listed)
- Ischemic stroke due to accidents or any trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D LevelVitamin D level is measured upon the presentation of the case with ischemic stroke | Diagnostic test | – |
Primary outcome
Correlation of Vitamin D level and the Incidence of Ischemic Stroke
Time frame: On admission
Correlation Analyses between vitamin D and ischemic stroke will be applies
1 secondary outcome
impact of vitamin D on ischemic stroke in relationship with gender
Time frame: On admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No. Data of study participants will be kept confidential and no intention for distribution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed FLeifel, MD PhD study director
Abha International Private Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Abha International Private Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Vitamin D level and the Incidence of Ischemic Stroke (time frame: On admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.