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

NCT ID: NCT01857154

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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

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Osteopenia, Osteoporosis

Keywords

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Bone mineral density Bone mineral content Bone density Bone health Dual-energy x-ray absorptiometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3

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

Group Type ACTIVE_COMPARATOR

Micronized Calcium Carbonate

Intervention Type 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.

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3

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.

Group Type ACTIVE_COMPARATOR

Non-Micronized Calcium Carbonate

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Non-Micronized Calcium Carbonate/Vitamin D3

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.

Group Type ACTIVE_COMPARATOR

Non-Micronized Calcium Carbonate

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Micronized Calcium Carbonate/Vitamin D3

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

Group Type ACTIVE_COMPARATOR

Micronized Calcium Carbonate

Intervention Type 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.

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Integrative Health Technologies, Inc.

NETWORK

Sponsor Role lead

Responsible Party

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Gilbert R Kaats

Dr. Gilbert R. Kaats, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilbert R Kaats, PhD FACN

Role: PRINCIPAL_INVESTIGATOR

Integrative Health Technologies, Inc.

Harry G Preuss, MD MACN

Role: STUDY_CHAIR

Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology

Sidney J Stohs, PhD

Role: STUDY_DIRECTOR

Dean Emeritus, Creighton University Health Sciences Center

Locations

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Integrative Health Technologies

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Patricia L Keith, BBA

Role: primary

Mike Gale

Role: backup

Other Identifiers

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064

Identifier Type: -

Identifier Source: org_study_id