Role of Vitamin K2 in Chronic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo: Placebo match vitamin K2 capsules once per day.

Vitamin K 2: Patients will be treated with vitamin K2 (menaquinone-7) 90 mcg/day.

Study 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.

Eligibility

Primary outcome measure(s)

• 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 — The study duration will be 6 months
  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 change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g) — The study duration will be 6 months
  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 change in blood pressure (mmHg) will be done using a mercury sphygmomanometer — The study duration will be 6 months
  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 change in Blood urea nitrogen (BUN) (mg/dl) — The study duration will be 6 months
  Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
• The change in serum potassium (meq/l). — The study duration will be 6 months
  Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
• The change in serum creatinine (mg/dl) — The study duration will be 6 months
  Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
• The change in serum urea (mg/dl) — The study duration will be 6 months
  Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI

Trial sites (1)

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