Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis

June 15, 2024 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis: a Prospective Observational Clinical Trial

This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fasting from sunrise to sunset during the Islamic holy month of Ramadan is one of the five pillars of the Islamic faith. Duration of the fasting ranges from 10 to 18 hours per day according to the geographic location and the season. Although people with chronic illnesses are exempted from fasting according to Islamic beliefs, many patients insist on fasting against medical advice. Through the last three decades many reports studied the potential risks and benefits of fasting Ramadan in regular hemodialysis (HD) patients. Target points of investigation were different. Most of them were focusing on the electrolytes and nutritional changes. Fewer reports tested the mortality rate. In a multicenter observational study, 2055 Egyptian patients from 25 HD units were studied for frequency of fasting in Ramadan and the possible effect of fasting on clinical and biochemical variables. The investigators concluded that nearly 47% of the study patients fasted at least few days of Ramadan. They recommended that HD patients should be encouraged to discuss the option of fasting in Ramadan with their HD staff who might be able to give advice on whether to allow them to fast in days off dialysis with special precautions regarding associated comorbidities, especially diabetes and coronary artery disease. Most of the studies focused on the effects of fasting the month of Ramadan in CKD and hemodialysis patients, but no research assessed these effects specifically in patients with glomerulonephritis.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

one hundred patients with biopsy proven glomerulonephritis for more than 3 months from different centers in Egypt will be enrolled in the study

Description

Inclusion Criteria:

  • Patients with biopsy proven glomerulonephritis with eGFR ≥ 30 ml/min for more than 3 months (exception is nephrotic patients with positive anti-PLA2R indicative of primary membranous).

Exclusion Criteria:

  • Patients with medical contraindications for fasting.
  • Patients with eGFR < 30 ml/min.
  • Patients with acute cardiovascular disease.
  • uncontrolled diabetes mellitus.
  • active or chronic inflammatory disease.
  • Acute liver disease.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fasting
100 patients who decided to fast the month of ramadan.
Behavioral: fasting month of ramadan
100 patients with glomerulonephritis who decided to fast month of ramadan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in kidney function
Time Frame: 4 weeks (month of ramadan)
By assessing change in eGFR
4 weeks (month of ramadan)
Change in proteinuria
Time Frame: 4 weeks (month of ramadan)
By assessing change in protein to creatinine ratio in urine
4 weeks (month of ramadan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Mamdouh Elsayed, MD, Assistant Professor
  • Study Chair: kariem M salem, MD, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2024

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fasting ramadan in GN patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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