Alfacalcidol
Dietary Supplement0.25 mcg 3x per week for 6 weeks
NCT Number: NCT01774812
Despite advances in treatment of conventional cardiovascular risk factors, patients with kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects approximately 2 million Canadians; however, this patient population remains grossly understudied due to the complex nature of the disease. The inadequacy of the literature to address the cardiovascular-related mortality rates in those with kidney disease reflects the urgent need for investigation of novel risk factors.
One cardiovascular risk factor which has recently been validated is the clinical measurement of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in concert with one another to control heart rate. CAT can be quantified computer analysis of heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording. Abnormal CAT, which occurs when the autonomic system does not control heart rate properly in response to physical demands or stress, is associated with risk of adverse cardiovascular events in both healthy and high risk populations. It has recently been shown that patients with severe kidney disease demonstrate significant CAT abnormalities, thus exaggerated susceptibility to cardiac death.
Vitamin D (VD) deficiency is also common in this patient population due to the fact that the kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established cardiovascular risk factor on its own, it is possible that kidney disease patients experienced compounded risk due to the combination of VD deficiency and abnormal CAT. However, no study has ever investigated whether VD deficiency influences CAT in healthy or diseased populations. To our knowledge, this will be the first trial to ever examine the effect, if any, of different VD supplementation treatments (standard of care vs. combination) on CAT in a population burdened with overwhelming risk and incidence of cardiovascular and sudden cardiac death risk.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Foothills Medical Centre - University of Calgary, Calgary, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.25 mcg 3x per week for 6 weeks
50,000IU 1x per week for 6 weeks
Time frame: change from baseline to 6 weeks
Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
Time frame: change from 6 weeks to 18 weeks
Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
Time frame: change from 18 weeks to 24 weeks
Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
Time frame: every 6 weeks up to 24 weeks
standard deviation of normal wave (heart rate variability time domain)
Time frame: every 6 weeks up to 24 weeks
standard deviation of the average normal wave (heart rate variability time domain)
Time frame: every 6 weeks up to 24 weeks
percentage of normal waves which differ in frequency > 50 ms compared to the wave directly before (heart rate variability time domain)
Time frame: every 6 weeks up to 24 weeks
Low-frequency (ms squared and normalized units), thought to reflect sympathetic contribution from the cardiac autonomic nervous system
Time frame: every 6 weeks up to 24 weeks
High-frequency (ms squared and normalized units), thought to reflect parasympathetic contribution from the cardiac autonomic nervous system
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
Time frame: every 6 weeks up to 24 weeks
renin, angiotensin II, aldosterone
University of Calgary
Other
Vitamin D Supplementation and Cardiac Autonomic Tone in Hemodialysis Patients: A Blinded, Randomized-controlled Trial
Acronym: VITAH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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