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Clinical Trial Details

Trial ID: L0029
Source ID: NCT05942053
Associated Drug: Placebo
Title: Role of Vitamin K2 in Chronic Kidney Disease
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Placebo|DRUG: Vitamin K 2
Outcome Measures: Primary: The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021, Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021., The study duration will be 6 months|The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g), Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g), The study duration will be 6 months|The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer, Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks., The study duration will be 6 months|The change in Blood urea nitrogen (BUN) (mg/dl), Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI, The study duration will be 6 months|The change in serum potassium (meq/l)., Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI, The study duration will be 6 months|The change in serum creatinine (mg/dl), Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI, The study duration will be 6 months|The change in serum urea (mg/dl), Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI, The study duration will be 6 months | Secondary: The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml), Evaluation of Chronic Kidney Disease-Mineral and Bone Disorder Chronic Kidney Disease-Mineral and Bone Disorder (CKD MBD) will be assessed at baseline and at the end of intervention through evaluation of: - Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml), The study duration will be 6 months.|The change in I-PTH (pg/ml), The change in I-PTH (pg/ml) will be assessed at baseline and at the end of intervention through evaluation, The study duration will be 6 months.|The change in vitamin D level (ng/ml), The change in vitamin D level (ng/ml) will be assessed at baseline and at the end of intervention through evaluation, The study duration will be 6 months.|The change in serum calcium level (mg/dl), The change in serum calcium level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation, The study duration will be 6 months.|The change in serum phosphorus level (mg/dl), The change in serum phosphorus level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation, The study duration will be 6 months.|Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire, Clinical outcome will be assessed at baseline and 6 months after Intervention through: - Evaluation of Health Related Quality of Life (HRQOL) using the validated Arabic version of -Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire which was formerly used in Egypt for patients with CKD., The study duration will be 6 months.
Sponsor/Collaborators: Sponsor: Tanta University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-15
Completion Date: 2025-07-15
Results First Posted:
Last Update Posted: 2024-11-27
Locations: Faculty of Pharmacy Tanta University, Tanta, Capital Of Gharbia Governorate., 31527, Egypt
URL: https://clinicaltrials.gov/show/NCT05942053