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The purpose of this study is to determine whether consuming calcium carbonate that has been micronized is more effective than the traditional form of calcium carbonate in maintaining or increasing bone mineral density in people who are currently taking bisphosphonates or other bone-health medications.
Addressing the need for a form of supplemental calcium that could facilitate increases in BMD without the adverse effects often reported with limestone-based forms of calcium, a patented technology was developed to increase calcium absorbability using both Zet Mill/Ball Mill bottom-up pulverizing technology and 4D top-down ebonite charging technology to create a novel form of calcium referred to as micronized calcium carbonate (MCC). In comparison to other technologies that use water and high heat, which results in a loss of core nutrients and decreased product efficacy, the calcium produced by this unique pulverizing technology is micron-sized (0.03um - 10um) and therefore believed to be more effective. While its tiny size was thought to increase its absorption, the belief was that the intense activation of zinc via the patented ebonite charging process that could maximize the bioavailability of this calcium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3 | Active Comparator | Subjects currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total amount of 500 mg of Micronized Calcium Carbonate and 800 IU Vitamin D3 |
|
| Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3 | Active Comparator | Subjects currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total amount of 1000 mg of Non-Micronized Calcium Carbonate and 800 IU Vitamin D3. |
|
| Non-Micronized Calcium Carbonate/Vitamin D3 | Active Comparator | Subjects who are not currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total of 1000 mg of Non-Micronized Calcium Carbonate and 800 IU Vitamin D3. |
|
| Micronized Calcium Carbonate/Vitamin D3 | Active Comparator | Subjects who are not currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total of 500 mg of Micronized Calcium Carbonate and 800 IU Vitamin D3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized Calcium Carbonate | Dietary Supplement | Subjects currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry | Bone density scanning, also called dual-energy x-ray absorptiometry (DXA) or bone densitometry, is an enhanced form of x-ray technology that is used to measure bone mineral density. Imaging with x-rays involves exposing a part of the body to a small dose of ionizing radiation to produce pictures of the inside of the body. Benefits
| 0 and 183 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Chemistry Panel | 43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein | 0 and 183 days |
| Systolic and Diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert R Kaats, PhD FACN | Integrative Health Technologies, Inc. | Principal Investigator |
| Harry G Preuss, MD MACN | Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology | Study Chair |
| Sidney J Stohs, PhD | Dean Emeritus, Creighton University Health Sciences Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Health Technologies | Recruiting | San Antonio | Texas | 78209 | United States |
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| Non-Micronized Calcium Carbonate | Dietary Supplement | Subjects currently being treated with bisphosphonates will be administered 1000 mg non-micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 1000 mg non- micronized calcium carbonate. |
|
| Vitamin D3 | Dietary Supplement | All subjects in the study cohort will be administered 800 IU Vitamin D3. |
|
Measures the amount of force (pressure) that blood exerts on the walls of blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study.
| 0 and 183 days |
| Resting heart rate | Measure of heart rate after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study. | 0 and 183 days |
| Self-reported quality of life | 0 and 183 days |
| Number of participants with adverse effects | Participants will have opportunity to report on a weekly basis an adverse effects experienced | up to 183 days |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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