Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-04 @ 12:15 AM
Study NCT ID:
NCT06531993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010368', 'term': 'Pectins'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-27', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-07-27', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of pectin in GFR improvement in ckd patients', 'timeFrame': '6 month', 'description': 'Measure eGFR using CKD epi equation,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.efsa.europa.eu/en/efsajournal/pub/4866', 'label': 'Related Info'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6341125/', 'label': 'Related Info'}, {'url': 'http://dx.doi.org/10.21203/rs.3.rs-3689543/v1', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Effect of pectin in chronic kidney disease patients', 'detailedDescription': 'Chronic kidney disease (CKD) is a serious global health problem leading to serious comorbidities, end-stage renal disease (ESRD), and death\n\nFrom 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.\n\nIn 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 .\n\nPectin, 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).\n\nAmong 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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of CKD patients (stage 3 and 4)\n2. age between 18 and 60 years\n3. Must be able to swallow tablets\n\nExclusion Criteria:\n\n1- End stage renal disease ( stage 5 ) 2 - Patients with renal transplantation 3- pregnancy 4- Presence of malignancy'}, 'identificationModule': {'nctId': 'NCT06531993', 'briefTitle': 'Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )', 'orgStudyIdInfo': {'id': 'Pectin in CKD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pectin group', 'description': 'Pectin treatment', 'interventionNames': ['Drug: Pectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placepo group', 'description': 'Standard of care', 'interventionNames': ['Drug: Pectin']}], 'interventions': [{'name': 'Pectin', 'type': 'DRUG', 'description': 'Using pectin as tablets 600 mg per day for 6 months', 'armGroupLabels': ['Pectin group', 'Placepo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maha Gamal Mahmoud, Resident', 'role': 'CONTACT', 'email': 'gamalmaha749@gmail.com', 'phone': '01555004150'}, {'name': 'Ashraf Anwer Thabt, Prof', 'role': 'CONTACT', 'email': 'ashrafshazly58@gmail.com'}], 'overallOfficials': [{'name': 'Ashraf Anwer Thabet', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prof'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Maha Gamal Mahmoud Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}