Clinical trial NCT05302713: Antiorbital Calcium in Chronic Conditions
Official title: Evaluating Changes in Quality of Life and Epigenetic Methylation From Antiorbital Ionic Calcium in Older Adults With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
calcium
supplements
antiorbital ionic calcium
quality of life
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Rate of Biological Aging
timeFrame: Baseline
measure: Rate of Biological Aging
timeFrame: Week 12
measure: Rate of Biological Aging
timeFrame: Week 24
measure: Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain
timeFrame: Baseline
measure: Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain
timeFrame: Week 2
measure: Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain
timeFrame: Week 6
measure: Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain
timeFrame: Week 12
measure: Patient Reported Outcomes Measurement Information system-29 Physical Function Sub-domain
timeFrame: Week 24
Secondary outcomes:
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Baseline
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Week 2
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Week 6
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Week 12
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: Week 24
measure: Changes in Cognition
timeFrame: Baseline
measure: Changes in Cognition
timeFrame: Week 6
measure: Changes in Cognition
timeFrame: Week 12
measure: Changes in Cognition
timeFrame: Week 24
measure: Changes in Mood
timeFrame: Baseline
measure: Changes in Mood
timeFrame: Week 2
measure: Changes in Mood
timeFrame: Week 6
measure: Changes in Mood
timeFrame: Week 12
measure: Changes in Mood
timeFrame: Week 24
measure: Changes in Anxiety
timeFrame: Baseline
measure: Changes in Anxiety
timeFrame: Week 2
measure: Changes in Anxiety
timeFrame: Week 6
measure: Changes in Anxiety
timeFrame: Week 12
measure: Changes in Anxiety
timeFrame: Week 24
measure: Changes in Pain and Disability
timeFrame: Baseline
measure: Changes in Pain and Disability
timeFrame: Week 2
measure: Changes in Pain and Disability
timeFrame: Week 6
measure: Changes in Pain and Disability
timeFrame: Week 12
measure: Changes in Pain and Disability
timeFrame: Week 24
Other outcomes:
measure: Coronary Artery Calcium Score
timeFrame: Week 12
measure: Coronary Artery Calcium Score
timeFrame: Week 24
measure: Ultrasonometer Bone Densitometry
timeFrame: Week 12
measure: Ultrasonometer Bone Densitometry
timeFrame: Week 24
measure: Activated Partial Thromboplastin Time
timeFrame: Week 2
measure: Activated Partial Thromboplastin Time
timeFrame: Week 6
measure: Activated Partial Thromboplastin Time
timeFrame: Week 12
measure: Activated Partial Thromboplastin Time
timeFrame: Week 24
measure: Prothrombin Time
timeFrame: Week 2
measure: Prothrombin Time
timeFrame: Week 6
measure: Prothrombin Time
timeFrame: Week 12
measure: Prothrombin Time
timeFrame: Week 24
measure: Internationalized Normalized Ratio
timeFrame: Week 2
measure: Internationalized Normalized Ratio
timeFrame: Week 6
measure: Internationalized Normalized Ratio
timeFrame: Week 12
measure: Internationalized Normalized Ratio
timeFrame: Week 24
measure: Thrombin Time
timeFrame: Week 12
measure: Thrombin Time
timeFrame: Week 24
measure: Concentration of Serum Calcium (ionic)
timeFrame: Week 12
measure: Concentration of BUN (serum)
timeFrame: Week 2
measure: Concentration of BUN (serum)
timeFrame: Week 6
measure: Concentration of BUN (serum)
timeFrame: Week 12
measure: Concentration of BUN (serum)
timeFrame: Week 24
measure: Concentration of Creatinine (serum)
timeFrame: Week 2
measure: Concentration of Creatinine (serum)
timeFrame: Week 6
measure: Concentration of Creatinine (serum)
timeFrame: Week 12
measure: Concentration of Creatinine (serum)
timeFrame: Week 24
measure: Glomerular Filtration Rate, estimated (eGFR)
timeFrame: Week 2
measure: Glomerular Filtration Rate, estimated (eGFR)
timeFrame: Week 6
measure: Glomerular Filtration Rate, estimated (eGFR)
timeFrame: Week 12
measure: Glomerular Filtration Rate, estimated (eGFR)
timeFrame: Week 24
measure: Concentration of Alanine aminotransferase (serum)
timeFrame: Week 2
measure: Concentration of Alanine aminotransferase (serum)
timeFrame: Week 6
measure: Concentration of Alanine aminotransferase (serum)
timeFrame: Week 12
measure: Concentration of Alanine aminotransferase (serum)
timeFrame: Week 24
measure: Concentration of Aspartate aminotransferase (serum)
timeFrame: Week 2
measure: Concentration of Aspartate aminotransferase (serum)
timeFrame: Week 6
measure: Concentration of Aspartate aminotransferase (serum)
timeFrame: Week 12
measure: Concentration of Aspartate aminotransferase (serum)
timeFrame: Week 24
measure: Concentration of Thyroid Stimulating Hormone
timeFrame: Week 2
measure: Concentration of Thyroid Stimulating Hormone
timeFrame: Week 6
measure: Concentration of Thyroid Stimulating Hormone
timeFrame: Week 12
measure: Concentration of Thyroid Stimulating Hormone
timeFrame: Week 24
measure: Concentration of Calcitonin
timeFrame: Week 12
measure: Concentration of Osteocalcin
timeFrame: Week 12
measure: Concentration of Bone-Specific Alkaline Phosphatase
timeFrame: Week 12
measure: Concentration of Procollagen Type I Intact N Terminal Propeptide (PINP)
timeFrame: Week 12
measure: Concentration of Collagen Type I C-Telopeptide (CTx)
timeFrame: Week 12
Locations:
city: Portland
country: United States
facility: Helfgott Research Institute
state: Oregon
Study officials:
affiliation: National University of Natural Medicine
name: Ryan Bradley
role: PRINCIPAL_INVESTIGATOR
References: