Vitamin D and Cardiac Autonomic Tone in Hemodialysis (VITAH)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Sudden Cardiac Death |
Dietary Supplement: Alfacalcidol Dietary Supplement: Ergocalciferol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Vitamin D Supplementation and Cardiac Autonomic Tone in Hemodialysis Patients: A Blinded, Randomized-controlled Trial |
- LF:HF [ Time Frame: change from baseline to 6 weeks ] [ Designated as safety issue: No ]Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
- LF:HF [ Time Frame: change from 6 weeks to 18 weeks ] [ Designated as safety issue: No ]Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
- LF:HF [ Time Frame: change from 18 weeks to 24 weeks ] [ Designated as safety issue: No ]Low frequency to high frequency ratio (sympathetic vs. parasympathetic cardiac autonomic power)
- SDNN [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]standard deviation of normal wave (heart rate variability time domain)
- SDANN [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]standard deviation of the average normal wave (heart rate variability time domain)
- pNN50% [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]percentage of normal waves which differ in frequency > 50 ms compared to the wave directly before (heart rate variability time domain)
- LF [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]Low-frequency (ms squared and normalized units), thought to reflect sympathetic contribution from the cardiac autonomic nervous system
- HF [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]High-frequency (ms squared and normalized units), thought to reflect parasympathetic contribution from the cardiac autonomic nervous system
- 25-hydroxy vitamin D [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- 1,25-dihydroxyvitamin D [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Parathyroid hormone [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Calcium [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Phosphate [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Pre- and post-dialysis weight [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]systolic, diastolic
- Kt/V [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Epinephrine [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Norepinephrine [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]
- Renin-angiotensin system activity (circulating) [ Time Frame: every 3 weeks up to 24 weeks ] [ Designated as safety issue: No ]renin, angiotensin II, aldosterone
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin D Sequence 1
6 weeks - alfacalcidol 0.25mcg + placebo 3x per week, 12 week washout, 6 weeks - alfacalcidol 0.25mcg 3x per week + 50,000IU ergocalciferol 1x per week (placebo the 2 remaining days)
|
Dietary Supplement: Alfacalcidol
0.25 mcg 3x per week for 6 weeks
Dietary Supplement: Ergocalciferol
50,000IU 1x per week for 6 weeks
|
|
Active Comparator: Vitamin D Treatment Sequence 2
6 weeks - alfacalcidol 0.25mcg 3x per week + 50,000IU ergocalciferol 1x per week (placebo the 2 remaining days), 12 week washout, 6 weeks - alfacalcidol 0.25mcg + placebo 3x per week
|
Dietary Supplement: Alfacalcidol
0.25 mcg 3x per week for 6 weeks
Dietary Supplement: Ergocalciferol
50,000IU 1x per week for 6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Contact: Dr. Sofia B Ahmed, MD, MMSc | (403) 944-2745 | sofia.ahmed@albertahealthservices.ca |
| Contact: Michelle C Mann, PhD(c.), BSc | (403) 479-2908 | mcmann@ucalgary.ca |
| Canada, Alberta | |
| Sheldon M. Chumir Health Centre | Recruiting |
| Calgary, Alberta, Canada, T2R 0X7 | |
| Contact: Janice Mackay, RN, CNeph (403) 955-6387 janice.mackay@albertahealthservices.ca | |
| Contact: Troy Hamilton 403-955-6385 tdhamilt@ucalgary.ca | |
| Principal Investigator: Dr. Sofia B Ahmed, MD, MMSc | |
| Foothills Medical Centre - University of Calgary | Not yet recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Contact: Darlene Sola, RN, BScN (403) 944-2745 dsola@ucalgary.ca | |
| Principal Investigator: Dr. Sofia B Ahmed, MD, MMSc | |
| Northland Hemodialysis Clinic | Not yet recruiting |
| Calgary, Alberta, Canada, T2L 2J8 | |
| Principal Investigator: Dr. Sofia B Ahmed, MD, MMSc | |
| Principal Investigator: | Dr. Sofia B Ahmed, MD, MMSc | University of Calgary |
| Principal Investigator: | Dr. Derek Exner, MD, MPH | University of Calgary, Libin Cardiovascular Institute |
| Principal Investigator: | Dr. Brenda Hemmelgarn, MD, PhD, MN | University of Calgary |
More Information
Publications:
| Responsible Party: | Sofia Ahmed, Dr. Sofia B. Ahmed, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT01774812 History of Changes |
| Other Study ID Numbers: | UC-Neph-2012001 |
| Study First Received: | January 17, 2013 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
vitamin D hemodialysis sudden cardiac death heart rate variability cardiac autonomic tone |
Additional relevant MeSH terms:
|
Death, Sudden, Cardiac Cardiovascular Diseases Death Pathologic Processes Heart Arrest Heart Diseases Death, Sudden 1-hydroxycholecalciferol Ergocalciferols |
Vitamin D Hydroxycholecalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013