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Trial record 8 of 29 for:    high dose vitamin k

Effects of Fhytomenadione on Coronary Artery Calcification of Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247087
Recruitment Status : Completed
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
Marco Antonio Ocampo Apolonio
Rodolfo Guardado Mendoza
Texar Alfonso Pereyra Nobara
Information provided by (Responsible Party):
Hilda Elizabeth Macias Cervantes, Instituto Mexicano del Seguro Social

Brief Summary:

Until 2013 the reported incidence of chronic kidney disease varied widely between countries, reporting the highest prevalence Taiwan, the region of Jalisco in Mexico and United States, with 458, 421 and 363 individuals per million inhabitants respectively. Mexico has around 52,000 patients in replacement therapies, of which 80% of patients are treated in the Instituto Mexicano del Seguro Social (IMSS).

In each stage of renal disease the principal cause of mortality is cardiovascular disease. The risk of cardiovascular mortality is greater than the general population. Arterial calcification, a marker of atherosclerosis and cardiovascular mortality predictor is common in chronic kidney disease. The presence of arterial calcification leads to an increase in arterial stiffness and to a decrease in coronary perfusion resulting in cardiac hypertrophy and myocardial ischemia.

The presence of traditional cardiovascular risk factors like diabetes, hypertension, hyperlipidemia and old age cannot fully explain the high prevalence of atherosclerosis and arterial calcification in chronic kidney disease. Another specific factors related to chronic kidney disease, like hyperphosphatemia, high calcium concentration in dialysis solutions, use of high doses of vitamin D for the management of hyperparathyroidism has been shown to positively influence development of arterial calcification. Invitro studies show that in presence of hyperphosphatemia smooth muscle cells are transformed into osteoblast-like cells that can express proteins that regulate mineralization. Two of this proteins, the matrix Gla protein (MGP) and osteocalcin (OC) are regulators of tissue mineralization in arterial walls and bones respectively. Vitamin K is required as cofactor in the gamma-carboxylation process of several extracellular matrix proteins, converting inactive carboxylated proteins to carboxylated active proteins. Prothrombin and coagulation factors 7,9 y 10 require vitamin K2 for its carboxylation process, while osteocalcin and the matrix Gal protein require vitamin K1. Matrix Gla protein is a calcification inhibitor that plays an important role in the prevention of arterial calcification. For carboxylation and correct function of the MGP is necessary an enzymatic cofactor, vitamin K; this is corroborated in the fact that the antagonism of vitamin K with warfarin antagonizes the carboxylation of MGP and produces rapid arterial calcification.

There are currently no studies evaluating vitamin K in the prevention of vascular calcification in patients with chronic kidney disease, therefore, the role of vitamin K in the patient with kidney disease needs to be clarified with randomized controlled studies, in which the target will be this population of patients at high risk. The aim of this study is evaluate the effect of phytomenadione on coronary artery calcification of patients on hemodialysis compared to placebo, our research hypothesis is that phytomenadione slows the progression and favors the regression of coronary arterial calcification in patients on hemodialysis compared to placebo, evaluating the coronary calcium score by coronary tomography. As secondary objectives was determine changes in the baseline coronary calcium score and at 12 months of use of phytomenadione and presence of cardiovascular events like acute myocardial infarction, unstable angina and death of cardiac cause. The intervention group received phytomenadione 10 mg (1 vial in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months and the control group 1 vial of placebo solution (solution for injection in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months. The follow-up of the patients was for 12 months, at the end of the follow-up, a coronary control tomography was performed by the Radiology Department to assess the final calcium score. Relative risk measurement (RR), absolute risk reduction (ARR) and number to be treated (NTT) were performed.


Condition or disease Intervention/treatment Phase
Coronary Calcification Drug: phytomenadione Drug: placebo solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial with double blinding compared to placebo
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients were randomly assigned to receive intravenous vitamin K or placebo solution. Coronary tomography was performed and interpreted by Radiology staff, who had no knowledge about the study groups or their intervention
Primary Purpose: Treatment
Official Title: Effects of Fhytomenadione on Coronary Artery Calcification of Hemodialysis Patients. Randomized Clinical Trial
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
phytomenadione 10 mg (1 vial in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
Drug: phytomenadione
phytomenadione 10 mg (1 vial in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
Other Name: vitamin K

Placebo Comparator: Control group
1 vial of placebo solution (solution for injection in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
Drug: placebo solution
1 vial of placebo solution (solution for injection in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
Other Name: solution for injection




Primary Outcome Measures :
  1. coronary calcium score [ Time Frame: 12 months ]
    Within the population of hemodialysis patients, patients who met the inclusion criteria were sought, once the participation in the study was accepted and an informed consent was signed, a coronary tomography was performed and interpreted by Radiology staff, who had no knowledge about the study groups or their intervention. Those patients who fulfilled the coronary calcification tomographic criterion defined as coronary calcium score of 10 Agatston units were randomized to receive the intervention or the placebo. At the end of the 12 month follow-up, a coronary tomography was performed again to quantify the final Agatston score


Secondary Outcome Measures :
  1. cardiovascular events [ Time Frame: 12 months ]
    determine presence of cardiovascular events like acute myocardial infarction, unstable angina and death of cardiac cause during follow-up. The presence of events will be determined according to the clinical record in the patient's file



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic kidney disease in hemodialysis
  • Patients who have 6 months or more on hemodialysis
  • Patients over 18 years
  • Patients that meet the tomographic criterion of a coronary calcium score of 10 Agatston units.

Exclusion Criteria:

  • Patients in previous or current treatment with phytomenadione
  • Coronary stent patients
  • Patients with arrhythmias and requiring oral anticoagulation with warfarin or acenocoumarin
  • Pregnant patients
  • Patients who undergo renal transplantation during the follow-up period
  • Patients who change the modality to peritoneal dialysis during the follow-up period
  • Patients who are known allergy to vitamin K

Information from the National Library of Medicine

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): NCT04247087


Locations
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Mexico
Hospital de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos
Leon, Guanajuato, Mexico, 37260
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Marco Antonio Ocampo Apolonio
Rodolfo Guardado Mendoza
Texar Alfonso Pereyra Nobara
Investigators
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Principal Investigator: Hilda E Macias Cervantes, Doctor Instituto Mexicano del Seguro Social
Study Chair: Marco A Ocampo Apolonio, Doctor Instituto Mexicano del Seguro Social
Study Director: Rodolfo Guardado Mendonza, Doctor Universidad de Guanajuato
Study Chair: Texar A Pereyra Nobara, Doctor Instituto Mexicano del Seguro Social
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Hilda Elizabeth Macias Cervantes, Doctor, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT04247087    
Other Study ID Numbers: 1
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hilda Elizabeth Macias Cervantes, Instituto Mexicano del Seguro Social:
coronary calcification
phytomenadione
chronic kidney disease
hemodialysis
Additional relevant MeSH terms:
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Vitamin K
Vitamin K 1
Vitamins
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Micronutrients
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants