Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National University of Natural Medicine
Age
55–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults 55-75 years of age
Active diagnosis of one of the following conditions:
Stage 1 Hypertension with Non-valvular Atrial Fibrillation (AF) - 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.), self-reported but previously diagnosed by a healthcare professional;
Stage 1 Hypertension (systolic blood pressure of 130-139, diastolic blood pressure of 80-89), self-reported but previously diagnosed by a healthcare professional;
or, Osteoarthritis, self-reported but previously diagnosed by a healthcare professional.
If diagnosed with AF, a European Heart Rhythm Association (EHRA) score of 2b or greater (i.e. Normal daily activity not affected by symptoms related to AF, but patient troubled by symptoms).
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
Willing to have desktop ultrasound of wrist done on 3 occasions.
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.
You may not be if
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), thromboembolism, or Cerebrovascular Accident (CVA)/Stroke.
Use of dihydropyridine or non-dihydropyridine calcium channel blockers for any reason
If diagnosed with atrial fibrillation, not on a stable dose of anti-coagulant or anti-platelet prescription medications (i.e., consistent dose for a minimum of three months)
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 atrial fibrillation, hypertension, or osteoarthritis) 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)
Are allergic to corn.
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 who experience menstrual periods, 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, rheumatologist, orthopedist, etc.) managing their atrial fibrillation, hypertension, or osteoarthritis.
Current use of: dietary supplements or medications utilized for chelation purposes (i.e., ethylenediaminetetraacetic acid; EDTA), or of chemotherapeutic agents.
