Skip to content

Vitamin D and Cardiac Autonomic Tone in Hemodialysis

Vitamin D Supplementation and Cardiac Autonomic Tone in Hemodialysis Patients: A Blinded, Randomized-controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01774812
Acronym
VITAH
Enrollment
56
Registered
2013-01-24
Start date
2013-01-31
Completion date
2015-03-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Sudden Cardiac Death

Keywords

vitamin D, hemodialysis, sudden cardiac death, heart rate variability, cardiac autonomic tone

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTAlfacalcidol

0.25 mcg 3x per week for 6 weeks

DIETARY_SUPPLEMENTErgocalciferol

50,000IU 1x per week for 6 weeks

Sponsors

Alberta Innovates Health Solutions
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age ≥ 18 years * 3x weekly hemodialysis outpatient within Calgary for at least 3 months prior to enrolment * physician consent to participate in VD supplementation regimen * ability and agreement to cease any VD medication for 4 weeks prior to initiation of study * able to comprehend study and provide oral and written consent in English

Exclusion criteria

* any major cardiovascular event (new onset arrhythmia, hospitalization for a cardiac event) noted in patient chart within the 6 month period prior to initiation of the study * currently on VD therapy/refusal to cease VD therapy for 4 weeks prior to initiation of study * physician anticipates death or adverse event within the next year- known discharge from hemodialysis (transfer to peritoneal dialysis, kidney transplant)

Design outcomes

Primary

MeasureTime frameDescription
LF:HFchange from baseline to 6 weeksLow frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)

Secondary

MeasureTime frameDescription
SDANNevery 6 weeks up to 24 weeksstandard deviation of the average normal wave (heart rate variability time domain)
pNN50%every 6 weeks up to 24 weekspercentage of normal waves which differ in frequency \> 50 ms compared to the wave directly before (heart rate variability time domain)
LFevery 6 weeks up to 24 weeksLow-frequency (ms squared and normalized units), thought to reflect sympathetic contribution from the cardiac autonomic nervous system
HFevery 6 weeks up to 24 weeksHigh-frequency (ms squared and normalized units), thought to reflect parasympathetic contribution from the cardiac autonomic nervous system
SDNNevery 6 weeks up to 24 weeksstandard deviation of normal wave (heart rate variability time domain)

Other

MeasureTime frameDescription
Epinephrineevery 6 weeks up to 24 weeks
25-hydroxy vitamin Devery 6 weeks up to 24 weeks
Renin-angiotensin system activity (circulating)every 6 weeks up to 24 weeksrenin, angiotensin II, aldosterone
Norepinephrineevery 6 weeks up to 24 weeks
1,25-dihydroxyvitamin Devery 6 weeks up to 24 weeks
Parathyroid hormoneevery 6 weeks up to 24 weeks
Calciumevery 6 weeks up to 24 weeks
Phosphateevery 6 weeks up to 24 weeks
Pre- and post-dialysis weightevery 6 weeks up to 24 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026