Antiorbital Calcium in Chronic Conditions

NCT ID: NCT05302713

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Ionic Calcium

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.

Group Type: EXPERIMENTAL

Ionic Calcium

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type: DIETARY_SUPPLEMENT

Calcium carbonate supplementation in a solution identical in appearance, consistency, and taste to the intervention supplement.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Calcium Carbonate

Calcium carbonate supplementation in a solution identical in appearance, consistency, and taste to the intervention supplement.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

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), 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.
• MoCA score of 16 or less upon screening.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Natural Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ryan Bradley

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Bradley

Role: PRINCIPAL_INVESTIGATOR

National University of Natural Medicine

Locations

Helfgott Research Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

RB121521

Identifier Type: -

Identifier Source: org_study_id