Antiorbital Calcium in Atrial Fibrillation (AntiAFib)

This is an interventional other trial for Atrial Fibrillation focused on measuring atrial fibrillation, calcium, supplements, antiorbital ionic calcium, quality of life Read More

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