Clinical Trial

Role of Vitamin K2 in Chronic Kidney Disease

Recruiting Phase 4
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Record status
This record was last updated June 24, 2025 (before its estimated July 14, 2026 completion). Its status may not reflect the trial's current state.
Summary
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Vitamin K2 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium \< 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups. Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match vitamin K2 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Group 2: Vitamin K2 (menaquinone-7) Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and vitamin K2 capsules (menaquinone-7) 90 mcg/day. The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-04; most recent amendment 2025-06-17.
Status change: Not Yet Recruiting → Recruiting 2024-01-14
Trial Details
NCT Number NCT05942053
Lead Sponsor Tanta University
Conditions Chronic Kidney Diseases
Enrollment 44 participants
Start Date 2023-07-15
Primary Completion 2026-07-14 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-24