RecruitingPhase 4NCT05942053

Role of Vitamin K2 in Chronic Kidney Disease

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


Sponsor

Tanta University

Enrollment

44 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Vitamin K2 supplements can slow the progression of chronic kidney disease (CKD) and reduce vascular calcification (calcium build-up in blood vessels), which is common in people with kidney disease. **You may be eligible if...** - You are 18 years old or older - You have chronic kidney disease (CKD) not yet on dialysis, with moderate kidney function (eGFR 30–89 mL/min — stages 2 to 3b) - You have protein in your urine (albumin-to-creatinine ratio of 30 mg/g or higher) - Your CKD has been present for a similar duration to other participants (matched) **You may NOT be eligible if...** - You are already on dialysis - You have very severe kidney disease (eGFR below 30) - You are taking blood thinners (anticoagulants like warfarin) that interact with Vitamin K - You have conditions that would make interpreting Vitamin K2 effects unreliable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Placebo match vitamin K2 capsules once per day.

DRUGVitamin K 2

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


Locations(1)

Faculty of Pharmacy Tanta University

Tanta, Capital of Gharbia Governorate., Egypt

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NCT05942053


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