Not provided
Not provided
Not provided
Not provided
No participants were enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Systolic and Diastolic Blood Pressure | Objective measure of blood pressure | Baseline |
| Changes in Systolic and Diastolic Blood Pressure | Objective measure of blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Calcium Score | Composite Coronary Artery Calcium Score | Week 12 |
| Coronary Artery Calcium Score | Composite Coronary Artery Calcium Score |
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Bradley | National University of Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helfgott Research Institute | Portland | Oregon | 97201 | United States |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| Calcium Carbonate | Dietary Supplement | Calcium carbonate supplementation in a solution identical in appearance, consistency, and taste to the intervention supplement. |
|
| Week 24 |
| Week 2 |
| Changes in Systolic and Diastolic Blood Pressure | Objective measure of blood pressure | Week 6 |
| Changes in Systolic and Diastolic Blood Pressure | Objective measure of blood pressure | Week 12 |
| Changes in Systolic and Diastolic Blood Pressure | Objective measure of blood pressure | Week 24 |
| Changes in Cognition | MoCA Assessment Score | Baseline |
| Changes in Cognition | MoCA Assessment Score | Week 6 |
| Changes in Cognition | MoCA Assessment Score | Week 12 |
| Changes in Cognition | MoCA Assessment Score | Week 24 |
| Changes in Mood | Patient Health Questionnaire-9 Score | Baseline |
| Changes in Mood | Patient Health Questionnaire-9 Score | Week 2 |
| Changes in Mood | Patient Health Questionnaire-9 Score | Week 6 |
| Changes in Mood | Patient Health Questionnaire-9 Score | Week 12 |
| Changes in Mood | Patient Health Questionnaire-9 Score | Week 24 |
| Changes in Anxiety | Generalized Anxiety Disorder-7 Score | Baseline |
| Changes in Anxiety | Generalized Anxiety Disorder-7 Score | Week 2 |
| Changes in Anxiety | Generalized Anxiety Disorder-7 Score | Week 6 |
| Changes in Anxiety | Generalized Anxiety Disorder-7 Score | Week 12 |
| Changes in Anxiety | Generalized Anxiety Disorder-7 Score | Week 24 |
| Changes in Pain and Disability | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | Baseline |
| Changes in Pain and Disability | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | Week 2 |
| Changes in Pain and Disability | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | Week 6 |
| Changes in Pain and Disability | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | Week 12 |
| Changes in Pain and Disability | Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score | Week 24 |
| Week 24 |
| Ultrasonometer Bone Densitometry | Bone density T score resulting from ultrasound | Week 12 |
| Ultrasonometer Bone Densitometry | Bone density T score resulting from ultrasound | Week 24 |
| Activated Partial Thromboplastin Time | Measure of blood coagulation | Week 2 |
| Activated Partial Thromboplastin Time | Measure of blood coagulation | Week 6 |
| Activated Partial Thromboplastin Time | Measure of blood coagulation | Week 12 |
| Activated Partial Thromboplastin Time | Measure of blood coagulation | Week 24 |
| Prothrombin Time | Measure of blood coagulation | Week 2 |
| Prothrombin Time | Measure of blood coagulation | Week 6 |
| Prothrombin Time | Measure of blood coagulation | Week 12 |
| Prothrombin Time | Measure of blood coagulation | Week 24 |
| Internationalized Normalized Ratio | Measure of blood coagulation | Week 2 |
| Internationalized Normalized Ratio | Measure of blood coagulation | Week 6 |
| Internationalized Normalized Ratio | Measure of blood coagulation | Week 12 |
| Internationalized Normalized Ratio | Measure of blood coagulation | Week 24 |
| Thrombin Time | Measure of blood coagulation | Week 12 |
| Thrombin Time | Measure of blood coagulation | Week 24 |
| Concentration of Serum Calcium (ionic) | Measure of non-protein bound calcium concentration in the serum | Week 12 |
| Concentration of BUN (serum) | Measure of renal function and protein turnover | Week 2 |
| Concentration of BUN (serum) | Measure of renal function and protein turnover | Week 6 |
| Concentration of BUN (serum) | Measure of renal function and protein turnover | Week 12 |
| Concentration of BUN (serum) | Measure of renal function and protein turnover | Week 24 |
| Concentration of Creatinine (serum) | Measure of renal function | Week 2 |
| Concentration of Creatinine (serum) | Measure of renal function | Week 6 |
| Concentration of Creatinine (serum) | Measure of renal function | Week 12 |
| Concentration of Creatinine (serum) | Measure of renal function | Week 24 |
| Glomerular Filtration Rate, estimated (eGFR) | Measure of renal function | Week 2 |
| Glomerular Filtration Rate, estimated (eGFR) | Measure of renal function | Week 6 |
| Glomerular Filtration Rate, estimated (eGFR) | Measure of renal function | Week 12 |
| Glomerular Filtration Rate, estimated (eGFR) | Measure of renal function | Week 24 |
| Concentration of Alanine aminotransferase (serum) | Measure of liver function | Week 2 |
| Concentration of Alanine aminotransferase (serum) | Measure of liver function | Week 6 |
| Concentration of Alanine aminotransferase (serum) | Measure of liver function | Week 12 |
| Concentration of Alanine aminotransferase (serum) | Measure of liver function | Week 24 |
| Concentration of Aspartate aminotransferase (serum) | Measure of liver function | Week 2 |
| Concentration of Aspartate aminotransferase (serum) | Measure of liver function | Week 6 |
| Concentration of Aspartate aminotransferase (serum) | Measure of liver function | Week 12 |
| Concentration of Aspartate aminotransferase (serum) | Measure of liver function | Week 24 |
| Concentration of Thyroid Stimulating Hormone | Measure of thyroid activity | Week 2 |
| Concentration of Thyroid Stimulating Hormone | Measure of thyroid activity | Week 6 |
| Concentration of Thyroid Stimulating Hormone | Measure of thyroid activity | Week 12 |
| Concentration of Thyroid Stimulating Hormone | Measure of thyroid activity | Week 24 |
| Concentration of Calcitonin | Measure of bone formation | Week 12 |
| Concentration of Osteocalcin | Measure of bone formation | Week 12 |
| Concentration of Bone-Specific Alkaline Phosphatase | Measure of bone turnover | Week 12 |
| Concentration of Procollagen Type I Intact N Terminal Propeptide (PINP) | Measure of bone formation | Week 12 |
| Concentration of Collagen Type I C-Telopeptide (CTx) | Measure of bone resorption | Week 12 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |