Evaluating Vitamin K2's Role 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

This study is testing if adding Vitamin K2 to the blood pressure medication ramipril can help people with chronic kidney disease feel better and improve their health over six months.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tanta University (other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Tanta, Capital of Gharbia Governorate.)
• Trial ID: NCT05942053 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Vitamin K2 as an adjuvant therapy alongside an ACE inhibitor, ramipril, in patients with chronic kidney disease (CKD) stages 2-3b. It is a randomized, placebo-controlled, double-blind study involving 44 non-dialysis CKD patients, focusing on outcomes such as blood pressure, proteinuria, and bone metabolism over a six-month period. Participants will be stratified and randomized into two groups: one receiving ramipril and a placebo, and the other receiving ramipril and Vitamin K2. The study aims to assess whether Vitamin K2 can improve kidney function and related health markers in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with non-dialysis chronic kidney disease stages 2-3b and newly diagnosed hypertension.

Not a fit: Patients with diabetes, heart disease, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to improve kidney health and reduce complications in patients with chronic kidney disease.

How similar studies have performed: While the role of Vitamin K2 in CKD is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Tanta, Capital of Gharbia Governorate.

• Faculty of Pharmacy Tanta University — Tanta, Capital of Gharbia Governorate., Egypt (RECRUITING)

Study contacts

• Principal investigator: Tarek Mostafa, PhD — Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, 31527
• Study coordinator: Dina Abdel Hamid, Masters

Conditions: Chronic Kidney Diseases, Proteinuria, Bone Metabolism, Vitamin K2