Evaluating Vitamin K2's Role in Chronic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: pg_87899@pharm.tanta.edu.eg
• Phone: +2001020198970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.