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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916030
Other study ID # IRB0000871535
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2016
Est. completion date January 3, 2017

Study information

Verified date July 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 especially stroke.


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 )


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 3, 2017
Est. primary completion date January 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum 25 (OH) D levels serum 25 (OH) D levels Within the first 24 hours
Secondary Stroke severity Stroke severity will be assessed by Scandinavian Stroke scale Stroke (SSS) Within the first 24 hours
Secondary Stroke etiology Within the first 24 hours
Secondary Stroke risk factors Within the first 24 hours
Secondary Stroke subtypes Within the first 24 hours
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