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

Chronic Kidney Diseases

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

Inclusion Criteria7

Age ≥ 18 years old.
Both sexes.
Patients matched in the duration of CKD.
Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b).
Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
Patients with serum Potassium \< 5 mEq/L.
A newly diagnosed patients with hypertension.

Exclusion Criteria13

Patients with elevated level of potassium ≥ 5 mEq/L.
Patients with diabetes.
Patients with cancer.
Patients with heart disease.
Patients with hepato-biliary disease and other liver diseases.
Patients with kidney stones and urinary tract infection.
Patients with an overactive thyroid gland.
Patients with bleeding disorder.
History of drug allergy to ACEI or ARBs.
Pregnant and breastfeeding women.
Patients with blood pressure ≥180/110 or \<100/60.
Patients on alteplase, azothiopurine, everolimus, sirolimus, lithium, non-steroidal anti-inflammatory drugs (epifenac, tenoxicam, Celecoxib….), potassium retentive diuretics (amiloride, spironolactone), other ACEIs and ARBs will be excluded to avoid possible drug-drug interactions with ramipril.
Patients on omega-3 fatty acids; vitamins (especially A, C, E, K), Chemotherapy and oral anticoagulant (warfarin), cholestyramine, orlistate will be excluded to avoid possible drug interactions that could affect vitamin K2