Antiorbital Calcium in Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to determine the mechanistic effects of an ionic calcium supplement in adults with atrial fibrillation. The study aims to determine if ionic calcium supplementation affects quality of life, rate of biological aging, fibrillation frequency, bone densitometry, and blood biomarkers of bone metabolism over a six month period compared to non-ionic calcium comparator supplement.

Official Title
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Evaluating Changes in Epigenetic Methylation From Antiorbital Ionic Calcium in Adults With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Dietary Supplement: Ionic Calcium
* Dietary Supplement: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ● Adults 18-70 years of age Active diagnosis of non-valvular atrial fibrillation - including paroxysmal, persistent, or long-standing persistent AF with typical electrocardiographic characteristics (i.e., absence of identifiable p-waves with irregularly irregular ventricular rate) without known complications, heart disease, or congenital heart defects (e.g., rapid ventricular rate, recent myocardial infarction, heart failure, stroke, cardiomyopathy, etc.) and/or with a formal diagnosis from a healthcare professional. A European Heart Rhythm Association (EHRA) score greater than 1 (i.e., mild symptoms, normal daily activity not affected). On a stable dose of all medications prior to study entry (i.e., consistent dose for a minimum of three months) Willing to be randomized to take daily ionized calcium as a dietary supplement or placebo over the 24-week study period On a stable dose of dietary supplements for at least one month prior to enrollment Willing to avoid initiation of new supplements and/or medications unless otherwise indicated by a healthcare professional Willing to have blood drawn on 6 occasions, and fast for 10-12 hours before blood draws, over the study period Able to communicate via email, complete computer-administered questionnaires, and to read and write in English. Must be able to provide written informed consent Non-smokers (including tobacco and cannabis products, combusted or vaporized) Approved to be eligible for study participation at the discretion of the Principal Investigators, after review of the Formal Eligibility Screen results. Willing to avoid taking dietary supplements containing the following ingredients for the 24 weeks of study involvement: additional supplemental calcium in any form, vitamin D, vitamin K, selenium, magnesium, or zinc. Exclusion Criteria: ● Individuals with a current or past diagnosis of permanent AF Individuals with any thyroid or parathyroid disorders, or current use of thyroid medication for any reason. Individuals with chronic kidney or liver disease, cancer, colorectal disease, and other rare disorders. Individuals with a current diagnosis of Congestive Heart Failure (CHF). Individuals with a current or past diagnosis of Traumatic Brain Injury (TBI) or Cerebrovascular Accident (CVA)/Stroke. Use of dihydropyridine or non-dihydropyridine calcium channel blockers for any reason Not on a stable dose of anti-coagulant or anti-platelet prescription medications (i.e., consistent dose for a minimum of three months) CHA2DS2-VASC score of ≥ 2 and NOT on a stable dose (i.e. stable for at least 3 months) of oral anti-coagulant medication/therapy. HAS-BLED score ≥ 3 Abnormalities in coagulation studies (e.g., INR ≤ 2 or ≥ 3.0) or hypercalcemia at the clinical screening visit. Blood pressure ≥ 140/90 mmHg at the clinical screening visit. Current involvement or within 14 days prior to screening of a significant diet or weight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast, and/or HMR) Hospitalization (for any reason other than a scheduled medical procedure unrelated to AF) within 3 months prior to screening Cardiac surgery within 3 months prior to screening Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix) Women who are lactating, pregnant or planning pregnancy within the next six months Intake of ≥ 2 standardized alcohol-containing beverages per day, 14 per week, or ≥4 in any single day within the past 14 days. Women of child-bearing age, who are sexually active and are unwilling to use an appropriate form of contraception during the duration of the trial. Smoking tobacco or nicotine products (combusted or vaporized) Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening Currently participating in another interventional research study, or participated in another interventional research study within 14 days of screening Do not have an active primary care provider or specialist (i.e., cardiologist) managing their atrial fibrillation Current use of: dietary supplements or medications utilized for chelation purposes (i.e., ethylenediaminetetraacetic acid; EDTA), or of chemotherapeutic agents. Allergy to corn

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to take either an ionic calcium (IC) supplement or calcium carbonate (CC) supplement for 12 weeks. At the 12 week time point, all participants, whether having taken IC or CC for the first 12 weeks, will take the IC supplement for the final 12 weeks of the study in an open label fashion.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ionic Calcium<br>Ionic calcium (IC) is a calcium in a free ionic state. Participants will be instructed to take 8mg of IC/60kg body weight dissolved into approximately 500ml of purified water. Participants will titrate their dose at the start of the study as follows: days 1-3: 1 dose per day 30 min prior to a meal; Days 4-6: twice per day, 30 minutes before meals; from day seven onward, the full dosage of three times per day, 30 minutes before meals. | Dietary Supplement: Ionic Calcium<br>* Ionic calcium (IC), a calcium in a free ionic state (i.e., non-protein bound), is purported to improve calcium uptake and homeostasis leading to improved cellular signaling that may have been disrupted through environmental and lifestyle stressors.<br>|
| Active Comparator: Calcium Carbonate<br>Participants will be instructed to take 8mg of calcium carbonate/60kg body weight dissolved into approximately 500ml of purified water. Participants will titrate their dose at the start of the study as follows: days 1-3: 1 dose per day 30 min prior to a meal; Days 4-6: twice per day, 30 minutes before meals; from day seven onward, the full dosage of three times per day, 30 minutes before meals. | Dietary Supplement: Calcium Carbonate<br>* Calcium carbonate supplementation in a solution identical in appearance, consistency, and taste to the intervention supplement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Biological Aging | Dunedin PACE objective measure of the rate of epigenetic aging | Week 12 | 
| Rate of Biological Aging | Dunedin PACE objective measure of the rate of epigenetic aging | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation-specific health-related quality of life | Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | Week 12 | 
| Atrial fibrillation-specific health-related quality of life | Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, calcium, supplements, antiorbital ionic calcium, quality of life