Clinical trial NCT01857154: A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteopenia, Osteoporosis
Keywords: Bone mineral density
Bone mineral content
Bone density
Bone health
Dual-energy x-ray absorptiometry
Lead sponsor: Integrative Health Technologies, Inc.
Sponsor class: NETWORK
First posted: 2013-05-20
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
timeFrame: 0 and 183 days
Secondary outcomes:
measure: Blood Chemistry Panel
timeFrame: 0 and 183 days
measure: Systolic and Diastolic blood pressure
timeFrame: 0 and 183 days
measure: Resting heart rate
timeFrame: 0 and 183 days
measure: Self-reported quality of life
timeFrame: 0 and 183 days
measure: Number of participants with adverse effects
timeFrame: up to 183 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Integrative Health Technologies
state: Texas
Study officials:
affiliation: Integrative Health Technologies, Inc.
name: Gilbert R Kaats, PhD FACN
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
name: Harry G Preuss, MD MACN
role: STUDY_CHAIR
affiliation: Dean Emeritus, Creighton University Health Sciences Center
name: Sidney J Stohs, PhD
role: STUDY_DIRECTOR
References: