AzTrials
AzTrials

Atrial FibrillationAntiAFibNCT05302713

Antiorbital Calcium in Chronic Conditions

A study testing Ionic Calcium and Calcium Carbonate in people with Atrial Fibrillation, run by National University of Natural Medicine at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Ionic Calcium and Calcium Carbonate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 17Show fewer
  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Helfgott Research Institute

    Portland, Oregon, 97201

Other trials in United States

About this study

Official title: Evaluating Changes in Quality of Life and Epigenetic Methylation From Antiorbital Ionic Calcium in Older Adults With Chronic Conditions

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.

Being tested
Ionic Calcium, Calcium Carbonate
Keywords
atrial fibrillation, calcium, supplements, antiorbital ionic calcium, quality of life
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ionic CalciumDietary 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 CarbonateDietary supplement

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

Study groups in NCT05302713
Study groupRoleWhat they receive
Ionic CalciumExperimentalIonic 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.
Receives: Dietary Supplement: Ionic Calcium
Calcium CarbonateActive comparatorParticipants 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.
Receives: Dietary Supplement: Calcium Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Biological Aging

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

    Measured: Baseline

  2. Rate of Biological Aging

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

    Measured: Week 12

  3. Rate of Biological Aging

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

    Measured: Week 24

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

    Quality of Life

    Measured: Baseline

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

    Quality of Life

    Measured: Week 2

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

    Quality of Life

    Measured: Week 6

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

    Quality of Life

    Measured: Week 12

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

    Quality of Life

    Measured: Week 24

Secondary outcomes (24)

  1. Changes in Systolic and Diastolic Blood Pressure

    Objective measure of blood pressure

    Measured: Baseline

  2. Changes in Systolic and Diastolic Blood Pressure

    Objective measure of blood pressure

    Measured: Week 2

  3. Changes in Systolic and Diastolic Blood Pressure

    Objective measure of blood pressure

    Measured: Week 6

  4. Changes in Systolic and Diastolic Blood Pressure

    Objective measure of blood pressure

    Measured: Week 12

  5. Changes in Systolic and Diastolic Blood Pressure

    Objective measure of blood pressure

    Measured: Week 24

  6. Changes in Cognition

    MoCA Assessment Score

    Measured: Baseline

  7. Changes in Cognition

    MoCA Assessment Score

    Measured: Week 6

  8. Changes in Cognition

    MoCA Assessment Score

    Measured: Week 12

  9. Changes in Cognition

    MoCA Assessment Score

    Measured: Week 24

  10. Changes in Mood

    Patient Health Questionnaire-9 Score

    Measured: Baseline

  11. Changes in Mood

    Patient Health Questionnaire-9 Score

    Measured: Week 2

  12. Changes in Mood

    Patient Health Questionnaire-9 Score

    Measured: Week 6

  13. Changes in Mood

    Patient Health Questionnaire-9 Score

    Measured: Week 12

  14. Changes in Mood

    Patient Health Questionnaire-9 Score

    Measured: Week 24

  15. Changes in Anxiety

    Generalized Anxiety Disorder-7 Score

    Measured: Baseline

  16. Changes in Anxiety

    Generalized Anxiety Disorder-7 Score

    Measured: Week 2

  17. Changes in Anxiety

    Generalized Anxiety Disorder-7 Score

    Measured: Week 6

  18. Changes in Anxiety

    Generalized Anxiety Disorder-7 Score

    Measured: Week 12

  19. Changes in Anxiety

    Generalized Anxiety Disorder-7 Score

    Measured: Week 24

  20. Changes in Pain and Disability

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

    Measured: Baseline

  21. Changes in Pain and Disability

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

    Measured: Week 2

  22. Changes in Pain and Disability

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

    Measured: Week 6

  23. Changes in Pain and Disability

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

    Measured: Week 12

  24. Changes in Pain and Disability

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: No participants were enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302713
Sponsor's protocol ID
RB121521
Acronym
AntiAFib
Status last verified
Aug 2024
First submitted
16 Mar 2022
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ionic Calcium and Calcium Carbonate in people with Atrial Fibrillation, run by National University of Natural Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Biological Aging (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in