Actively Recruiting
Role of Vitamin K2 in Chronic Kidney Disease
Led by Tanta University · Updated on 2025-06-24
44
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Vitamin K2 in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- All genders
- Patients matched by duration of chronic kidney disease
- Non-dialysis CKD patients with estimated glomerular filtration rate (GFR) between 30 and 89 mL/min/1.73m2 (Stage 2-3b)
- Patients with albumin-to-creatinine ratio equal to or greater than 30 mg/g
- Patients with serum potassium less than 5 mEq/L
- Newly diagnosed patients with hypertension
You will not qualify if you...
- Patients with serum potassium level 5 mEq/L or higher
- Patients with diabetes
- Patients with cancer
- Patients with heart disease
- Patients with liver diseases including hepato-biliary conditions
- Patients with kidney stones or urinary tract infections
- Patients with overactive thyroid gland
- Patients with bleeding disorders
- History of allergy to ACE inhibitors or angiotensin receptor blockers
- Pregnant or breastfeeding women
- Patients with blood pressure 180/110 mmHg or higher, or below 100/60 mmHg
- Patients taking alteplase, azathioprine, everolimus, sirolimus, lithium, certain NSAIDs, potassium-sparing diuretics, other ACE inhibitors or ARBs
- Patients on omega-3 fatty acids, vitamins (especially A, C, E, K), chemotherapy, oral anticoagulants (such as warfarin), cholestyramine, or orlistat to avoid interactions affecting vitamin K2
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Pharmacy Tanta University
Tanta, Capital of Gharbia Governorate., Egypt, 31527
Actively Recruiting
Research Team
D
Dina Abdel Hamid, Masters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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