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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02720133
Other study ID # GR2
Secondary ID
Status Completed
Phase N/A
First received July 24, 2014
Last updated June 17, 2016
Start date July 2013
Est. completion date September 2015

Study information

Verified date June 2016
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority Tunisia: Office of Pharmacies and Medicines
Study type Observational [Patient Registry]

Clinical Trial Summary

Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.


Description:

This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with cardiovascular risk factors in stable conditions

- Ramadan fasting

Exclusion Criteria:

- Impossibility, contraindication or interruption of fasting

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
biochemical parameters
patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation. All these tests should be practice before, during and after Ramadan fasting for comparison.

Locations

Country Name City State
Tunisia Emergency Departement Monastir Non-US/Canada

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Attarzadeh Hosseini SR, Hejazi K. The effects of ramadan fasting and physical activity on blood hematological-biochemical parameters. Iran J Basic Med Sci. 2013 Jul;16(7):845-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other clopidogrel and aspirin related complications 5 years Yes
Primary all cause clinical complications 5 years No
Secondary evidence of acute coronary complications 5 years Yes
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