Antiorbital Calcium in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— AntiAFib  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05302713
• Other study ID #: RB121521
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: National University of Natural Medicine
• Contact: Ryan Bradley, ND, MPH
• Phone: 503-552-1862
• Email: rbradley[@]nunm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Dietary Supplement:
• Ionic Calcium
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.
• Calcium Carbonate
Calcium carbonate supplementation in a solution identical in appearance, consistency, and taste to the intervention supplement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University of Natural Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of Fibrillation Episodes	Kardia Mobile single lead ECG to measure fibrillation episodes; means over 1 week will be collected.	Week 12
Other	Frequency of Fibrillation Episodes	Kardia Mobile single lead ECG to measure fibrillation episodes; means over 1 week will be collected.	Week 24
Other	Coronary Artery Calcium Score	Composite CAC Score	Week 12
Other	Coronary Artery Calcium Score	Composite CAC Score	Week 24
Other	DEXA Bone Densitometry	Bone density T score resulting from DEXA	Week 12
Other	DEXA Bone Densitometry	Bone density T score resulting from DEXA	Week 24
Other	Ultrasonometer Bone Densitometry	Bone density T score resulting from ultrasound	Week 12
Other	Ultrasonometer Bone Densitometry	Bone density T score resulting from ultrasound	Week 24
Other	Activated Partial Thromboplastin Time	Measure of blood coagulation	Week 2
Other	Activated Partial Thromboplastin Time	Measure of blood coagulation	Week 6
Other	Activated Partial Thromboplastin Time	Measure of blood coagulation	Week 12
Other	Activated Partial Thromboplastin Time	Measure of blood coagulation	Week 24
Other	Prothrombin Time and Internationalized Normalized Ratio	Measure of blood coagulation	Week 2
Other	Prothrombin Time and Internationalized Normalized Ratio	Measure of blood coagulation	Week 6
Other	Prothrombin Time and Internationalized Normalized Ratio	Measure of blood coagulation	Week 12
Other	Prothrombin Time and Internationalized Normalized Ratio	Measure of blood coagulation	Week 24
Other	Thrombin Time	Measure of blood coagulation	Week 2
Other	Thrombin Time	Measure of blood coagulation	Week 6
Other	Thrombin Time	Measure of blood coagulation	Week 12
Other	Thrombin Time	Measure of blood coagulation	Week 24
Other	Concentration of Serum Calcium (ionic)	Measure of non-protein bound calcium concentration in the serum	Week 12
Other	Concentration of BUN (serum)	Measure of renal function and protein turnover	Week 2
Other	Concentration of BUN (serum)	Measure of renal function and protein turnover	Week 6
Other	Concentration of BUN (serum)	Measure of renal function and protein turnover	Week 12
Other	Concentration of BUN (serum)	Measure of renal function and protein turnover	Week 24
Other	Concentration of Creatinine (serum)	Measure of renal function	Week 2
Other	Concentration of Creatinine (serum)	Measure of renal function	Week 6
Other	Concentration of Creatinine (serum)	Measure of renal function	Week 12
Other	Concentration of Creatinine (serum)	Measure of renal function	Week 24
Other	Glomerular Filtration Rate, estimated (eGFR)	Measure of renal function	Week 2
Other	Glomerular Filtration Rate, estimated (eGFR)	Measure of renal function	Week 6
Other	Glomerular Filtration Rate, estimated (eGFR)	Measure of renal function	Week 12
Other	Glomerular Filtration Rate, estimated (eGFR)	Measure of renal function	Week 24
Other	Concentration of Alanine aminotransferase (serum)	Measure of liver function	Week 2
Other	Concentration of Alanine aminotransferase (serum)	Measure of liver function	Week 6
Other	Concentration of Alanine aminotransferase (serum)	Measure of liver function	Week 12
Other	Concentration of Alanine aminotransferase (serum)	Measure of liver function	Week 24
Other	Concentration of Aspartate aminotransferase (serum)	Measure of liver function	Week 2
Other	Concentration of Aspartate aminotransferase (serum)	Measure of liver function	Week 6
Other	Concentration of Aspartate aminotransferase (serum)	Measure of liver function	Week 12
Other	Concentration of Aspartate aminotransferase (serum)	Measure of liver function	Week 24
Other	Concentration of Thyroid Stimulating Hormone	Measure of thyroid activity	Week 2
Other	Concentration of Thyroid Stimulating Hormone	Measure of thyroid activity	Week 6
Other	Concentration of Thyroid Stimulating Hormone	Measure of thyroid activity	Week 12
Other	Concentration of Thyroid Stimulating Hormone	Measure of thyroid activity	Week 24
Other	Concentration of Calcitonin	Measure of bone formation	Week 12
Other	Concentration of Osteocalcin	Measure of bone formation	Week 12
Other	Concentration of Bone-Specific Alkaline Phosphatase	Measure of bone turnover	Week 12
Other	Concentration of Procollagen Type I Intact N Terminal Propeptide (PINP)	Measure of bone formation	Week 12
Other	Concentration of Collagen Type I C-Telopeptide (CTx)	Measure of bone resorption	Week 12
Primary	Rate of Biological Aging	Dunedin PACE objective measure of the rate of epigenetic aging	Week 12
Primary	Rate of Biological Aging	Dunedin PACE objective measure of the rate of epigenetic aging	Week 24
Secondary	Atrial fibrillation-specific health-related quality of life	Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire	Week 12
Secondary	Atrial fibrillation-specific health-related quality of life	Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire	Week 24