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Search / Trial NCT05942053

Role of Vitamin K2 in Chronic Kidney Disease

Launched by TANTA UNIVERSITY · Jul 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Proteinuria, Bone Metabolism, Vitamin K2

ClinConnect Summary

This clinical trial is investigating the effects of Vitamin K2 on patients with chronic kidney disease (CKD) who are not on dialysis. The study aims to understand if adding Vitamin K2 to a standard blood pressure medication called ramipril can help improve blood pressure, reduce protein in the urine, and support bone health in these patients. The trial will include 44 adults aged 18 and older with specific health conditions, such as newly diagnosed high blood pressure and certain kidney function levels.

Participants will be divided into two groups: one will receive ramipril along with a placebo (a non-active pill), while the other group will receive ramipril and actual Vitamin K2. The study will last for six months, and participants will receive regular follow-ups through phone calls and in-person meetings to ensure they are taking their medications as directed. It’s important to note that certain patients, such as those with high potassium levels, diabetes, or specific heart and liver conditions, will not be eligible to join the study. This research could provide valuable insights into how Vitamin K2 might benefit people with chronic kidney disease.

Gender

ALL

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

About Tanta University

Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.

Locations

Tanta, Capital Of Gharbia Governorate., Egypt

Patients applied

0 patients applied

Trial Officials

Tarek Mostafa, PhD

Principal Investigator

Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, 31527

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported