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Role of Vitamin K2 in Chronic Kidney Disease

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Jul 14, 2025 to Jul 14, 2026 Completion date: Jul 15, 2025 to Jul 15, 2026v4 Show 1 more changeShow less
    • Completion date: Jul 15, 2025 to Jul 15, 2026
  2. Primary completion date: Jul 15, 2024 to Jul 14, 2025v3
  3. Trial status: Not Yet Recruiting to Recruitingv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05942053
Lead Sponsor Tanta University
Conditions Chronic Kidney Diseases
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov