A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate

Integrative Health Technologies

Status: Unknown

Conditions: Osteopenia, Osteoporosis

Treatments: Dietary Supplement: Non-Micronized Calcium Carbonate; Dietary Supplement: Micronized Calcium Carbonate; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01857154

064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 4 patient groups

Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Micronized Calcium Carbonate

Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Non-Micronized Calcium Carbonate

Non-Micronized Calcium Carbonate/Vitamin D3

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Non-Micronized Calcium Carbonate

Micronized Calcium Carbonate/Vitamin D3

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Micronized Calcium Carbonate