Antiorbital Calcium in Chronic Conditions

NCT05302713 | Withdrawn

• 1 other identifier: RB121521
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

atrial fibrillation; calcium; supplements; antiorbital ionic calcium; quality of life

Outcome Measures

Primary Outcomes (8)

• Rate of Biological Aging

  Dunedin Pace of Aging Calculated objective measure of the rate of epigenetic aging

  Baseline

• Rate of Biological Aging

  Dunedin Pace of Aging Calculated objective measure of the rate of epigenetic aging

  Week 12

• Rate of Biological Aging

  Dunedin Pace of Aging Calculated objective measure of the rate of epigenetic aging

  Week 24

• Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain

  Quality of Life

  Baseline

• Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain

  Quality of Life

  Week 2

• Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain

  Quality of Life

  Week 6

• Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain

  Quality of Life

  Week 12

• Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain

  Quality of Life

  Week 24

Secondary Outcomes (24)

• Changes in Systolic and Diastolic Blood Pressure

  Baseline

• Changes in Systolic and Diastolic Blood Pressure

  Week 2

• Changes in Systolic and Diastolic Blood Pressure

  Week 6

• Changes in Systolic and Diastolic Blood Pressure

  Week 12

• Changes in Systolic and Diastolic Blood Pressure

  Week 24

Other Outcomes (48)

• Coronary Artery Calcium Score

  Week 12

• Coronary Artery Calcium Score

  Week 24

• Ultrasonometer Bone Densitometry

  Week 12

Study Arms (2)

Ionic Calcium

EXPERIMENTAL

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

Calcium Carbonate

ACTIVE COMPARATOR

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

Interventions

Ionic Calcium 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.

Ionic Calcium

Calcium Carbonate DIETARY_SUPPLEMENT

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

Calcium Carbonate

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)

You may not qualify 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Ryan Bradley

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)