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
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 25, 2013
November 1, 2013
1.3 years
May 8, 2013
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
Bone density scanning, also called dual-energy x-ray absorptiometry (DXA) or bone densitometry, is an enhanced form of x-ray technology that is used to measure bone mineral density. Imaging with x-rays involves exposing a part of the body to a small dose of ionizing radiation to produce pictures of the inside of the body. Benefits * DXA bone densitometry is a simple, quick and noninvasive procedure. * No anesthesia is required. * The amount of radiation used is extremely small-less than one-tenth the dose of a standard chest x-ray, and less than a day's exposure to natural radiation. * DXA bone density testing is the most accurate method available for the diagnosis of osteoporosis and is also considered an accurate estimate
0 and 183 days
Secondary Outcomes (5)
Blood Chemistry Panel
0 and 183 days
Systolic and Diastolic blood pressure
0 and 183 days
Resting heart rate
0 and 183 days
Self-reported quality of life
0 and 183 days
Number of participants with adverse effects
up to 183 days
Study Arms (4)
Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3
ACTIVE COMPARATORSubjects 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
Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3
ACTIVE COMPARATORSubjects 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/Vitamin D3
ACTIVE COMPARATORSubjects 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.
Micronized Calcium Carbonate/Vitamin D3
ACTIVE COMPARATORSubjects 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
Interventions
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.
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.
All subjects in the study cohort will be administered 800 IU Vitamin D3.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Integrative Health Technologies
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilbert R Kaats, PhD FACN
Integrative Health Technologies, Inc.
- STUDY CHAIR
Harry G Preuss, MD MACN
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
- STUDY DIRECTOR
Sidney J Stohs, PhD
Dean Emeritus, Creighton University Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Gilbert R. Kaats, PhD
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 20, 2013
Study Start
May 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
November 25, 2013
Record last verified: 2013-11