NCT02916030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2017

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

September 17, 2016

Last Update Submit

July 12, 2018

Conditions

Keywords

Vitamin DStrokeParathormone

Outcome Measures

Primary Outcomes (1)

  • serum 25 (OH) D levels

    serum 25 (OH) D levels

    Within the first 24 hours

Secondary Outcomes (4)

  • Stroke severity

    Within the first 24 hours

  • Stroke etiology

    Within the first 24 hours

  • Stroke risk factors

    Within the first 24 hours

  • Stroke subtypes

    Within the first 24 hours

Study Arms (2)

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

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

Interventions

Vit DDIETARY_SUPPLEMENT

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

Group 1 (hemorrhagic stroke)Group 2 (Ischemic stroke)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with first -ever acute onset stroke within seven days

You may qualify if:

  • Onset is within one week
  • Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 74111, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • sayed abd elshafy, MD

    associate professor of anesthesia and critical care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

September 17, 2016

First Posted

September 27, 2016

Study Start

September 1, 2016

Primary Completion

January 2, 2017

Study Completion

January 3, 2017

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations