Osteopenia, Osteoporosis
Conditions
Keywords
Bone mineral density, Bone mineral content, Bone density, Bone health, Dual-energy x-ray absorptiometry
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMicronized Calcium Carbonate
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.
DIETARY_SUPPLEMENTNon-Micronized Calcium Carbonate
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.
DIETARY_SUPPLEMENTVitamin D3
All subjects in the study cohort will be administered 800 IU Vitamin D3.
Sponsors
Integrative Health Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must currently be under the care of a physician and taking prescription medication for bone health * Must ensure with medical provider that there are no medical conditions that would preclude participation * Must be able to swallow capsules * Must be age 21 or above * Must agree to follow study requirements as set forth in Informed Consent
Exclusion criteria
* Men and women not currently taking prescription medication for bone health * Conditions that inhibit gastrointestinal absorption of supplements * Men and women less than 21 years of age * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry | 0 and 183 days | 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 * DXA bone densitometry is a simple, quick and noninvasive procedure. * No anesthesia is required. * The amount of radiation used is extremely small-less than one-tenth the dose of a standard chest x-ray, and less than a day's exposure to natural radiation. * DXA bone density testing is the most accurate method available for the diagnosis of osteoporosis and is also considered an accurate estimate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Chemistry Panel | 0 and 183 days | 43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein |
| Systolic and Diastolic blood pressure | 0 and 183 days | 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. |
| Resting heart rate | 0 and 183 days | Measure of heart rate after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study. |
| Self-reported quality of life | 0 and 183 days | — |
| Number of participants with adverse effects | up to 183 days | Participants will have opportunity to report on a weekly basis an adverse effects experienced |
Countries
United States
Outcome results
None listed