StrokeNCT02916030
Vitamin D and Stroke
An observational study of Stroke, run by Assiut University at 1 site in Egypt.
Trial summary
Stroke remains one of the most devastating neurological diseases, often causing death, or gross physical impairment. It is the second most common cause of death worldwide and a major cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute to the risk of cardiovascular disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vit D
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2016to 3 Jan 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with first -ever acute onset stroke within seven days
Who may be able to join
- Onset is within one week
- Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction
Who cannot join
- Cognitive and mental changes
- Recurrent stroke
- Hepatic and renal impairment
- Endocrinal diseases
- Steroid therapy
- Vitamin D or Ca supplementation
Show all 16Show fewer
- Previous fractures
- Bone diseases
- brain neoplasm,
- Autoimmune diseases
- History of acute and chronic inflammatory diseases
- Malignancy,
- Trauma
- Surgery
- Acute vascular diseases that occurred within four weeks prior the onset of stroke
- History myocardial infarction ˂3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D and Stroke: A Comparative Study to Risk Factors and Stroke Type
Stroke remains one of the most devastating neurological diseases, often causing death, or gross physical impairment. It is the second most common cause of death worldwide and a major cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute to the risk of cardiovascular disease especially stroke.
Read the detailed description
This case -control observational prospective study will conducted on fifty patients with first -ever acute onset stroke within seven days (25 patients with hemorrhagic stroke and 25 patients with ischemic stroke )
- Conditions
- Stroke
- Being tested
- Vit D
- Keywords
- Vitamin D, Stroke, Parathormone
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDietary supplement
It is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (hemorrhagic stroke) | All participants will be subjected to thorough history taking, full clinical and neurological examination. Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. Receives: Dietary Supplement: Vit D | |
| Group 2 (Ischemic stroke) | All participants will be subjected to thorough history taking, full clinical and neurological examination. Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. Receives: Dietary Supplement: Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25 (OH) D levels
serum 25 (OH) D levels
Measured: Within the first 24 hours
Secondary outcomes (4)
Stroke severity
Stroke severity will be assessed by Scandinavian Stroke scale Stroke (SSS)
Measured: Within the first 24 hours
Stroke etiology
Measured: Within the first 24 hours
Stroke risk factors
Measured: Within the first 24 hours
Stroke subtypes
Measured: Within the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion2 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, MD, Principal investigator, associate professor of anesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916030
- Sponsor's protocol ID
- IRB0000871535
- Status last verified
- Jul 2018
- First submitted
- 17 Sep 2016
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Stroke: A Comparative Study to Risk Factors and Stroke Type
- ClinicalTrials.gov ID
- NCT02916030
- Acronym / sponsor ID
- IRB0000871535
- Conditions
- Stroke
- Keywords
- Vitamin D, Stroke, Parathormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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.
Stroke remains one of the most devastating neurological diseases, often causing death, or gross physical impairment. It is the second most common cause of death worldwide and a major cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute to the risk of cardiovascular disease especially stroke.
Detailed description
This case -control observational prospective study will conducted on fifty patients with first -ever acute onset stroke within seven days (25 patients with hemorrhagic stroke and 25 patients with ischemic stroke )
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (hemorrhagic stroke) | – | Dietary Supplement: Vit DAll participants will be subjected to thorough history taking, full clinical and neurological examination. Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. |
| Group 2 (Ischemic stroke) | – | Dietary Supplement: Vit DAll participants will be subjected to thorough history taking, full clinical and neurological examination. Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with first -ever acute onset stroke within seven days
Key inclusion criteria (2 listed)
- Onset is within one week
- Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction
Key exclusion criteria (16 listed)
- Cognitive and mental changes
- Recurrent stroke
- Hepatic and renal impairment
- Endocrinal diseases
- Steroid therapy
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 |
|---|---|---|
| Vit DIt is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types | Dietary supplement | Group 1 (hemorrhagic stroke), Group 2 (Ischemic stroke) |
Primary outcome
serum 25 (OH) D levels
Time frame: Within the first 24 hours
serum 25 (OH) D levels
4 secondary outcomes
Stroke severity
Time frame: Within the first 24 hours
Stroke etiology
Time frame: Within the first 24 hours
Stroke risk factors
Time frame: Within the first 24 hours
Stroke subtypes
Time frame: Within the first 24 hours
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 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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.
sayed abd elshafy, MD principal investigator
associate professor of anesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 16 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
serum 25 (OH) D levels (time frame: Within the first 24 hours). 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 13 Jul 2018.