Vitamin D and Stroke

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02916030
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief 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 especially stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Dietary Supplement: Vit D

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

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Vitamin D and Stroke: A Comparative Study to Risk Factors and Stroke Type
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jan 2, 2017
• Actual Study Completion Date: Jan 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Vit D; It is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types
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.	Dietary Supplement: Vit D; It is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types

Outcome Measures

Primary Outcome Measures

1. serum 25 (OH) D levels [Within the first 24 hours]

   serum 25 (OH) D levels

Secondary Outcome Measures

1. Stroke severity [Within the first 24 hours]

   Stroke severity will be assessed by Scandinavian Stroke scale Stroke (SSS)

2. Stroke etiology [Within the first 24 hours]

3. Stroke risk factors [Within the first 24 hours]

4. Stroke subtypes [Within the first 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Onset is within one week

• Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction

Exclusion Criteria:

• Cognitive and mental changes

• Recurrent stroke

• Hepatic and renal impairment

• Endocrinal diseases

• Steroid therapy

• Vitamin D or Ca supplementation

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Assiut		Egypt	74111

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: sayed abd elshafy, MD, associate professor of anesthesia and critical care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University
• ClinicalTrials.gov Identifier: NCT02916030
• Other Study ID Numbers: IRB0000871535
• First Posted: Sep 27, 2016
• Last Update Posted: Jul 13, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Sayed Kaoud Abd-Elshafy, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University: Vitamin D; Stroke; Parathormone
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Jul 13, 2018