NCT02720133

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Typical duration 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

July 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

July 24, 2014

Last Update Submit

June 17, 2016

Conditions

Keywords

ramadan fastingvariation of biochemical parametersvariation of hematological parametersverify now assay

Outcome Measures

Primary Outcomes (1)

  • all cause clinical complications

    5 years

Secondary Outcomes (1)

  • evidence of acute coronary complications

    5 years

Other Outcomes (1)

  • clopidogrel and aspirin related complications

    5 years

Study Arms (1)

Patients with cardiovascular risk factors who fast Ramadan

Stable clinical and biochemical parameters before Ramadan fasting

Biological: biochemical parameters

Interventions

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.

Also known as: hematological parameters assay, verify now assay
Patients with cardiovascular risk factors who fast Ramadan

Eligibility Criteria

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

Stable patients with cardiovascular risk factors who fast during Ramadan

You may qualify if:

  • Patients with cardiovascular risk factors in stable conditions
  • Ramadan fasting

You may not qualify if:

  • Impossibility, contraindication or interruption of fasting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Departement

Monastir, Non-US/Canada, 5000, Tunisia

Location

Related Publications (3)

  • 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.

  • Bouida W, Beltaief K, Baccouche H, Sassi M, Dridi Z, Trabelsi I, Laaouiti K, Chakroun T, Hellara I, Boukef R, Sakly N, Hassine M, Added F, Razgallah R, Najjar F, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on aspirin resistance in type 2 diabetic patients. PLoS One. 2018 Mar 12;13(3):e0192590. doi: 10.1371/journal.pone.0192590. eCollection 2018.

  • Bouida W, Baccouche H, Sassi M, Dridi Z, Chakroun T, Hellara I, Boukef R, Hassine M, Added F, Razgallah R, Khochtali I, Nouira S; Ramadan Research Group. Effects of Ramadan fasting on platelet reactivity in diabetic patients treated with clopidogrel. Thromb J. 2017 Jun 2;15:15. doi: 10.1186/s12959-017-0138-0. eCollection 2017.

Related Links

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Semir Nouira, Pr.

    University Hospital Of Monastir Tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of departement

Study Record Dates

First Submitted

July 24, 2014

First Posted

March 25, 2016

Study Start

July 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations