Role of Vitamin K2 in Chronic Kidney Disease
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ClinicalTrials.gov Identifier: NCT05942053 |
Recruitment Status :
Recruiting
First Posted : July 12, 2023
Last Update Posted : January 17, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Diseases | Drug: Placebo Drug: Vitamin K 2 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 15, 2023 |
Estimated Primary Completion Date : | July 15, 2024 |
Estimated Study Completion Date : | July 15, 2025 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months. |
Drug: Placebo
Placebo match vitamin K2 capsules once per day. |
Active Comparator: 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. |
Drug: Vitamin K 2
Patients will be treated with vitamin K2 (menaquinone-7) 90 mcg/day.
Other Name: menaquinone-7 |
- The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021 [ Time Frame: The study duration will be 6 months ]Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021.
- The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g) [ Time Frame: The study duration will be 6 months ]Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g)
- The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer [ Time Frame: The study duration will be 6 months ]Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks.
- The change in Blood urea nitrogen (BUN) (mg/dl) [ Time Frame: The study duration will be 6 months ]Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
- The change in serum potassium (meq/l). [ Time Frame: The study duration will be 6 months ]Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
- The change in serum creatinine (mg/dl) [ Time Frame: The study duration will be 6 months ]Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
- The change in serum urea (mg/dl) [ Time Frame: The study duration will be 6 months ]Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
- The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml) [ Time Frame: The study duration will be 6 months. ]Evaluation of Chronic Kidney Disease-Mineral and Bone Disorder Chronic Kidney Disease-Mineral and Bone Disorder (CKD MBD) will be assessed at baseline and at the end of intervention through evaluation of: - Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)
- The change in I-PTH (pg/ml) [ Time Frame: The study duration will be 6 months. ]The change in I-PTH (pg/ml) will be assessed at baseline and at the end of intervention through evaluation
- The change in vitamin D level (ng/ml) [ Time Frame: The study duration will be 6 months. ]The change in vitamin D level (ng/ml) will be assessed at baseline and at the end of intervention through evaluation
- The change in serum calcium level (mg/dl) [ Time Frame: The study duration will be 6 months. ]The change in serum calcium level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation
- The change in serum phosphorus level (mg/dl) [ Time Frame: The study duration will be 6 months. ]The change in serum phosphorus level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation
- Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire [ Time Frame: The study duration will be 6 months. ]
Clinical outcome will be assessed at baseline and 6 months after Intervention through:
- Evaluation of Health Related Quality of Life (HRQOL) using the validated Arabic version of -Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire which was formerly used in Egypt for patients with CKD.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05942053
Contact: Dina Abdel Hamid, Masters | +2001020198970 | pg_87899@pharm.tanta.edu.eg |
Egypt | |
Faculty of Pharmacy Tanta University | Recruiting |
Tanta, Capital Of Gharbia Governorate., Egypt, 31527 | |
Contact: Tarek Mostafa, Doctorate Degree +2001154594035 tarek.mostafa@pharm.tanta.edu.eg |
Principal Investigator: | Tarek Mostafa, PhD | Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Egypt, 31527 |
Responsible Party: | Dina Zaki Mohamed Zaki Abdel Hamid, Clinical Pharmacist, Tanta University |
ClinicalTrials.gov Identifier: | NCT05942053 |
Other Study ID Numbers: |
Vitamin K2 in CKD |
First Posted: | July 12, 2023 Key Record Dates |
Last Update Posted: | January 17, 2024 |
Last Verified: | January 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Proteinuria, Bone Metabolism, Vitamin K2 |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes |
Vitamin K Vitamin K 2 Menaquinone 7 Vitamins Micronutrients Physiological Effects of Drugs Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |