Impact of Vitamin D on Acute Ischemic Stroke Prognosis | NCT03819452

Studies
Impact of Vitamin D on Acute Ischemic Stroke Prognosis

NCT03819452

Sponsor

Abha International Private Hospital

Status

Completed

Last Update Posted

Jan 28, 2019Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Vitamin D Level

Countries

Egypt
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Jan 25, 2019Actual

Completion Date

Jan 25, 2019Actual

First Submitted Date

Jan 25, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 28, 2019Actual

Name	Class
Mansoura University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D Level	Diagnostic Test	Vitamin D level is measured upon the presentation of the case with ischemic stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of Vitamin D level and the Incidence of Ischemic Stroke	Correlation Analyses between vitamin D and ischemic stroke will be applies	On admission

Secondary Outcomes

Measure	Description	Time Frame
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	On admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed ischemic stroke not older than 48 hours

Exclusion Criteria:

Ischemic stroke due to accidents or any trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients attending to hospital settings diagnosed with ischemic stroke are investigated to have low level of vitamin D

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed FLeifel, MD PhD	Abha International Private Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah	Dakahlia Governorate		Egypt
IQVIA

IPD Sharing Statement Module

Plan to Share IPD

Description

Data of study participants will be kept confidential and no intention for distribution.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided