NCT01857154

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

A Double-Blinded Randomized Controlled CER Study of Changes in Bone Mineral Density, Blood Chemistries, Self-Reported Quality of Life and Compliance as a Function of Consuming Micronized Versus Non-micronized Calcium Carbonate

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Integrative Health Technologies, Inc. · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteopenia, Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Micronized 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_SUPPLEMENT	Non-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_SUPPLEMENT	Vitamin D3	All subjects in the study cohort will be administered 800 IU Vitamin D3.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-05-20
• Last updated: 2013-11-25

Locations

1 site across 1 country: United States