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

NCT ID: NCT06531993

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

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Effect of pectin in chronic kidney disease patients

Detailed Description

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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 .

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pectin group

Pectin treatment

Group Type ACTIVE_COMPARATOR

Pectin

Intervention Type DRUG

Using pectin as tablets 600 mg per day for 6 months

Placepo group

Standard of care

Group Type PLACEBO_COMPARATOR

Pectin

Intervention Type DRUG

Using pectin as tablets 600 mg per day for 6 months

Interventions

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Pectin

Using pectin as tablets 600 mg per day for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Maha Gamal Mahmoud Ahmed

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Anwer Thabet

Role: STUDY_DIRECTOR

Prof

Central Contacts

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Maha Gamal Mahmoud, Resident

Role: CONTACT

01555004150

Ashraf Anwer Thabt, Prof

Role: CONTACT

Related Links

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Other Identifiers

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Pectin in CKD

Identifier Type: -

Identifier Source: org_study_id

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