Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 6:53 PM
Study NCT ID:
NCT07427069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Kidney Disease Associated Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum blood samples Routine blood tests will include biomarkers such as creatinine, albumin, blood urea nitrogen, GFR, hsCRP, vitamin D, platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), uric acid, ferritin, iron, phosphorus, calcium, and parathyroid hormone. The spot urine albumin-to-creatinine ratio (ACR) will be recorded.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Creatinine', 'timeFrame': 'Day 1', 'description': 'Creatinine is a waste product generated from muscle metabolism and excreted by the kidneys; its serum level is used to assess renal function.'}, {'measure': 'Albumin', 'timeFrame': 'Day 1', 'description': 'Albumin is the main serum protein synthesized by the liver that maintains plasma oncotic pressure; it provides information about nutritional status and kidney function.'}, {'measure': 'Blood urea nitrogen', 'timeFrame': 'Day 1', 'description': 'Blood urea nitrogen (BUN) represents the amount of nitrogen in the blood derived from urea, a byproduct of protein metabolism, and is an indicator of renal function.'}, {'measure': 'Glomerular filtration rate', 'timeFrame': 'Day 1', 'description': 'Glomerular filtration rate (GFR) indicates the volume of blood filtered by the kidneys per minute and is a key parameter for evaluating renal function.'}, {'measure': 'High-sensitivity C-reactive protein', 'timeFrame': 'Day 1', 'description': 'High-sensitivity C-reactive protein (hsCRP) is a sensitive marker used to detect low-grade systemic inflammation.'}, {'measure': 'Vitamin D', 'timeFrame': 'Day 1', 'description': 'Vitamin D is a fat-soluble vitamin that regulates calcium-phosphorus metabolism and plays a role in bone health and immune function.'}, {'measure': 'Uric acid', 'timeFrame': 'Day 1', 'description': 'Uric acid is the end product of purine metabolism, and elevated levels are associated with gout and kidney disease.'}, {'measure': 'Ferritin', 'timeFrame': 'Day 1', 'description': 'Ferritin is a protein responsible for iron storage in the body, and its serum level reflects iron stores.'}, {'measure': 'Iron', 'timeFrame': 'Day 1', 'description': 'Iron is an essential trace element involved in hemoglobin synthesis and oxygen transport.'}, {'measure': 'Phosphorus', 'timeFrame': 'Day 1', 'description': 'Phosphorus is an essential mineral involved in bone mineralization and cellular energy metabolism.'}, {'measure': 'Calcium', 'timeFrame': 'Day 1', 'description': 'Calcium is a vital mineral required for bone and dental health, muscle contraction, and nerve transmission.'}, {'measure': 'Parathyroid hormone', 'timeFrame': 'Day 1', 'description': 'Parathyroid hormone (PTH) is a hormone secreted by the parathyroid glands that regulates calcium and phosphorus balance.'}, {'measure': 'Platelet', 'timeFrame': 'Day 1', 'description': 'Platelets are anucleate blood cell fragments derived from megakaryocytes in the bone marrow, and their primary function is to participate in blood clot formation (hemostasis) to prevent bleeding.'}, {'measure': 'Lymphocyte', 'timeFrame': 'Day 1', 'description': 'Lymphocytes are key cells of the adaptive immune system and mainly consist of T cells, B cells, and natural killer (NK) cells; they generate specific immune responses against infections and foreign antigens.'}, {'measure': 'Neutrophil', 'timeFrame': 'Day 1', 'description': 'Neutrophils are the most abundant leukocytes in the innate immune system and constitute the first line of defense against bacterial infections by destroying microorganisms through phagocytosis.'}], 'primaryOutcomes': [{'measure': 'Dietary Inflammatory Index', 'timeFrame': 'Day 1', 'description': "The Dietary Inflammatory Index (DII) provides a score that measures the potential for a person's diet to cause inflammation in the body. This index is based on the pro- or anti-inflammatory effects of consumed foods and nutrients. Participants' 3-day food intake records will be entered into the system, and average daily energy intake, macronutrients, and micronutrients will be calculated. Based on the food records, average daily intake of 36 nutrients will be determined, and DII scores will be derived from these nutrient parameters. A lower score indicates a more antiinflammatory diet, while a higher score indicates a more proinflammatory diet."}], 'secondaryOutcomes': [{'measure': 'Clinical Periodontal Parameters (Plaque Index)', 'timeFrame': 'Day 1', 'description': "Plaque Index (PI) (Silness and Löe, 1964) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth.\n\nScore Description 0 No plaque.\n\n1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.\n2. Visible plaque along the gingival margin, forming a continuous band.\n3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces."}, {'measure': 'Clinical Periodontal Parameters (Gingival Index)', 'timeFrame': 'Day 1', 'description': "The Gingival Index is used to assess the presence and severity of gingival inflammation (gingivitis). Four surfaces of each tooth (buccal, lingual, mesial, distal) are examined visually and with a periodontal probe. The evaluation considers color changes, edema (swelling), tissue consistency, and bleeding on probing. Each surface is scored from 0 to 3. The average score per tooth is calculated, and then the overall average is used to determine the individual's GI score.\n\nScore Description 0 Healthy gingiva: normal color and texture, no bleeding\n\n1. Mild inflammation: slight color change and swelling, no bleeding on probing\n2. Moderate inflammation: redness, edema, soft tissue, bleeding on probing\n3. Severe inflammation: marked redness and swelling, ulceration, possible spontaneous bleeding"}, {'measure': 'Periodontal Clinical Parametres (Bleeding on Probing Index)', 'timeFrame': 'Day 1', 'description': 'This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation.\n\nScore Description: 0 No bleeding 1 Bleeding present (mild or severe)'}, {'measure': 'Periodontal Clinical Parametres (Probing Pocket Depth)', 'timeFrame': 'Day 1', 'description': 'Using a Williams periodontal probe, the distance between the gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.\n\nMeasurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket\n\n≥6 mm Deep periodontal pocket (advanced disease)'}, {'measure': 'Periodontal Clinical Parametres (Clinical Attachment Loss)', 'timeFrame': 'Day 1', 'description': 'Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.\n\nCAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss\n\n≥6 mm Severe attachment loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'periodontitis', 'diet', 'inflammation'], 'conditions': ['Chronic Kidney Disease', 'Periodontitis', 'Diet, Food and Nutrition']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the relationship between chronic kidney disease (CKD) and periodontitis, and to evaluate the potential mediating role of dietary inflammatory potential, measured by the Dietary Inflammatory Index (DII), in this association.\n\nThe main question it aims to answer is:\n\nDoes a pro-inflammatory diet, as reflected by a higher DII score, exacerbate periodontal inflammation in individuals with chronic kidney disease?\n\nParticipants will include adults diagnosed with CKD at various stages. Periodontal status will be assessed through clinical parameters such as probing depth, clinical attachment loss, and bleeding on probing. Dietary intake will be evaluated using a validated food frequency questionnaire, and DII scores will be calculated accordingly. The study will aim to observe and analyze whether dietary inflammation contributes to increased periodontal disease severity in CKD patients, potentially offering insight into modifiable risk factors relevant to both systemic and oral health.', 'detailedDescription': "This observational study will aim to investigate the association between chronic kidney disease (CKD) and periodontitis, with a specific focus on the potential role of dietary inflammatory potential measured by the Dietary Inflammatory Index (DII). Adult participants diagnosed with CKD will be enrolled and their periodontal status will be evaluated using standard clinical parameters, including plaque index, probing depth, clinical attachment loss, and bleeding on probing. Dietary intake data will be collected through a validated food frequency questionnaire, and individual DII scores will be calculated to estimate the inflammatory potential of each participant's diet. The study will analyze whether higher dietary inflammatory load is associated with increased periodontal disease severity in individuals with CKD. Findings from this study are expected to contribute to a better understanding of the interplay between systemic disease, oral health, and modifiable lifestyle factors such as diet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with chronic kidney disease who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n* Being diagnosed with Chronic Kidney Disease (having an eGFR below 60 ml/min/1.73 m² for at least 3 months or a urine albumin-to-creatinine ratio above 30 mg/g (proteinuria))\n* Having at least 20 teeth\n* Not having received periodontal therapy in the last 6 months\n* Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks\n* Not having any autoimmune disease, osteoporosis, or cancer\n* Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates\n* Not being pregnant\n* Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)\n* Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)\n* Not taking antioxidant supplements in the last 6 months\n\nExclusion Criteria:\n\n* Patients with an active infectious disease,\n* Those taking medications that could affect periodontal tissues,\n* History of endocarditis,\n* Recent antibiotic use (within 4 months),\n* Alcohol/drug use,\n* Psychological disorders,\n* Eating disorders,\n* Dementia,\n* Pregnancy and breastfeeding,\n* Patients who did not sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT07427069', 'briefTitle': 'Chronic Kidney Disease Associated Diet', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'The Role of Pro-Inflammatory Diet in Periodontal Tissue Destruction in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'KBHDiet09/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with chronic kidney disease', 'description': 'Chronic kidney disease is diagnosed if the eGFR is below 60 ml/min/1.73 m2 for at least 3 months or if the urine albumin-creatinine ratio is above 30 mg/g (proteinuria).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53200', 'city': 'Rize', 'state': 'Rize Province', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'centralContacts': [{'name': 'Oguz KOSE, Professor Dr.', 'role': 'CONTACT', 'email': 'oguz.kose@erdogan.edu.tr', 'phone': '+90 541 348 64 65'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Dilek KARADOĞAN', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}