Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients
Summary
The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo?
Description
At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the 3 major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in incident hemodialysis patients with a baseline CAC score of >= 30 Agatston Units compared to placebo? Secondary questions include: 1) Does phylloquinone reduce the progression of calcification in the thoracic aorta, aortic valve and mitral valve? and 2) Does phylloquinone decrease major cardiovascular events such as acute coronary syndrome, congestive heart failure, stroke, transient ischemic attack, amputation or revascularization procedure?
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Endstage Kidney Disease
Intervention
Vitamin K1, Chrystalline Lactose
Location
Kingston General Hospital
Kingston
Ontario
Canada
K7L 2V7
Status
Recruiting
Source
Clinical Evaluation Research Unit at Kingston General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01528800
- Information obtained from ClinicalTrials.gov on April 04, 2013
Medical and Biotech [MESH] Definitions
Lactose Intolerance
The condition resulting from the absence or deficiency of LACTASE in the MUCOSA cells of the GASTROINTESTINAL TRACT, and the inability to break down LACTOSE in milk for ABSORPTION. Bacterial fermentation of the unabsorbed lactose leads to symptoms that range from a mild indigestion (DYSPEPSIA) to severe DIARRHEA. Lactose intolerance may be an inborn error or acquired.
Vitamin K
A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
Lactose Factors
Plasmids which determine the ability of a bacterium to ferment lactose.
Clinical Trials
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
Vitamin D, Chronic Kidney Disease (CKD) and the Microcirculation
Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and...
To Study the Effect of Vitamin E and Vitamin C on Restless Leg Syndrome in Hemodialysis Patients
Oxidative stress has a role in uremic neuropathy and may be involved in RLS of ESRD patients.Vitamin E &Vitamin C are potential antioxidant supplement that are used in hemodialysis patient...
Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis
The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatme...
Amount of Lactose Causing Symptoms in Lactose Intolerant People
The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients has led to inappropriate dietary advice and treatment with drugs that conta...
PubMed Articles
Vitamin K: key vitamin in controlling vascular calcification in chronic kidney disease.
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease. Deficiencies in calcium-regulatory proteins directly...
Insulin resistance and vitamin D deficiency in patients with chronic kidney disease stage 2-3.
Vitamin D status and the relationship between serum 25(OH) vitamin D concentrations and the components of insulin resistance were examined in 120 patients with chronic kidney disease stage 2 and 3. In...
Over the past decade, vitamin D has generated considerable interest as potentially having important effects on the vasculature and the kidney. Animal and human data indicate that vitamin D suppresses...
Shining light on vitamin D trials in chronic kidney disease.
Vitamin D compounds may have extraskeletal functions. Chronic kidney disease (CKD) offers an opportunity to investigate these actions, as vitamin D deficiency is prevalent in this population and actio...
Vitamin D metabolism and activity in the parathyroid gland.
Parathormone (PTH) and vitamin D are two critical hormonal regulators of calcium homeostasis. An important cross-talk exists between the PTH and vitamin D hormonal systems. PTH enhances vitamin D hydr...
