Vitamin D and Stroke

Completed

• Conditions: Stroke
• Interventions: Dietary Supplement: Vit D

• Registration Number: NCT02916030
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-25
• Study First Posted: 2016-09-27
• Primary Completion: 2017-01-02
• Study Completion: 2017-01-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (Ischemic stroke)	Vit D	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.
Group 1 (hemorrhagic stroke)	Vit D	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.

Primary Outcome Measures

Name	Time	Method
serum 25 (OH) D levels	Within the first 24 hours	serum 25 (OH) D levels

Secondary Outcome Measures

Name	Time	Method
Stroke risk factors	Within the first 24 hours
Stroke subtypes	Within the first 24 hours
Stroke severity	Within the first 24 hours	Stroke severity will be assessed by Scandinavian Stroke scale Stroke (SSS)
Stroke etiology	Within the first 24 hours

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt