Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )

July 27, 2024 updated by: Maha Gamal Mahmoud Ahmed, Assiut University
Effect of pectin in chronic kidney disease patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD) is a serious global health problem leading to serious comorbidities, end-stage renal disease (ESRD), and death

From 1990 to 2016, the prevalence of CKD increased by 90% worldwide, which is closely tied to the increase in at-risk populations with diabetes mellitus (DM), hypertension (HTN), and prediabetes . It is estimated to be around 9.1 to 13.4%. This means there are about 700 million to over 800 million cases of CKD worldwide.

In 2017, CKD resulted in 1.2 million deaths and was the 12th leading cause of death worldwide . And in the same year, the estimated prevalence of CKD in Egypt was 7.1 million individuals, which means 106 patients/1000 population .

Pectin, a class of heteropolysaccharides based on polygalacturonic acid, is a safe and non-toxic natural food additive recommended by the Joint FAO/WHO Committee on Food Additives with no daily additive limit . Pectin is mainly obtained from apple pomace, citrus peels and sugar beets, ancurrently, commercial pectin contains ≥65% Gal-A (galacturonic acid).

Among the patients who tried to take the pectin, unexpectedly was found that the pectin had a significant effect on the rapid reduction of blood creatinine concentration in patients with chronic kidney disease. So, the authors followed up the physical examination indeces of chronic kidney disease patients who took the Pectin .

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of CKD patients (stage 3 and 4)
  2. age between 18 and 60 years
  3. Must be able to swallow tablets

Exclusion Criteria:

1- End stage renal disease ( stage 5 ) 2 - Patients with renal transplantation 3- pregnancy 4- Presence of malignancy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pectin group
Pectin treatment
Drug: Pectin
Using pectin as tablets 600 mg per day for 6 months
Placebo Comparator: Placepo group
Standard of care
Drug: Pectin
Using pectin as tablets 600 mg per day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of pectin in GFR improvement in ckd patients
Time Frame: 6 month
Measure eGFR using CKD epi equation,
6 month

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Ashraf Anwer Thabet, Prof

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.

Helpful Links

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 (Estimated)

August 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

July 27, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pectin in CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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