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
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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UNKNOWN
NA
160 participants
INTERVENTIONAL
2013-05-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
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
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.
Vitamin D3
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.
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.
Vitamin D3
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.
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.
Vitamin D3
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
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.
Vitamin D3
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.
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.
Vitamin D3
All subjects in the study cohort will be administered 800 IU Vitamin D3.
Eligibility Criteria
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Inclusion Criteria
* 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
* Conditions that inhibit gastrointestinal absorption of supplements
* Men and women less than 21 years of age
* Pregnant or breast feeding
21 Years
ALL
Yes
Sponsors
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Integrative Health Technologies, Inc.
NETWORK
Responsible Party
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Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
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
Countries
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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