Effect of Ramadan Fasting on Kidney Function and Proteinu... | NCT06327009

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

NCT06327009

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Jun 18, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Fasting Ramadan

Interventions

fasting month of ramadan

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2024Actual

Primary Completion Date

Apr 22, 2024Actual

Completion Date

Jun 14, 2024Actual

First Submitted Date

Mar 12, 2024

First Submission Date that Met QC Criteria

Mar 15, 2024

First Posted Date

Mar 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2024

Last Update Posted Date

Jun 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, assistant professor, Alexandria UniversityPrincipal Investigator

Lead Sponsor

Alexandria UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fasting		100 patients who decided to fast the month of ramadan.	Behavioral: fasting month of ramadan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fasting month of ramadan	Behavioral	100 patients with glomerulonephritis who decided to fast month of ramadan	fasting

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed Mamdouh Elsayed, MD	assistant professor	Principal Investigator
kariem M salem, MD	lecturer	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Aexandria University		Alexandria		21526	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23934679	Background	Sahin SB, Ayaz T, Ozyurt N, Ilkkilic K, Kirvar A, Sezgin H. The impact of fasting during Ramadan on the glycemic control of patients with type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes. 2013 Oct;121(9):531-4. doi: 10.1055/s-0033-1347247. Epub 2013 Aug 9.
31031370	Background	Megahed AF, El-Kannishy G, Sayed-Ahmed N. Status of fasting in Ramadan of chronic hemodialysis patients all over Egypt: A multicenter observational study. Saudi J Kidney Dis Transpl. 2019 Mar-Apr;30(2):339-349. doi: 10.4103/1319-2442.256841.

ID	Term
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases