Osteopenia, OsteoporosisNCT01857154
A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate
A study testing Micronized Calcium Carbonate, Non-Micronized Calcium Carbonate and Vitamin D3 in people with Osteopenia, Osteoporosis, run by Integrative Health Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Micronized Calcium Carbonate, Non-Micronized Calcium Carbonate and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Health Technologies
San Antonio, Texas, 78209
Patricia L Keith, BBA, 210-824-4200, hmrcenterstudy@gmail.com
Mike Gale, 210-824-4200
About this study
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
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.
Read the 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
- Being tested
- Micronized Calcium Carbonate, Non-Micronized Calcium Carbonate, Vitamin D3
- Keywords
- Bone mineral density, Bone mineral content, Bone density, Bone health, Dual-energy x-ray absorptiometry
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized Calcium CarbonateDietary 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.
Non-Micronized Calcium CarbonateDietary 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 D3Dietary supplement
All subjects in the study cohort will be administered 800 IU Vitamin D3.
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3 | Active comparator | 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 Receives: Dietary Supplement: Micronized Calcium Carbonate; Dietary Supplement: Vitamin D3 |
| Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3 | Active comparator | 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. Receives: Dietary Supplement: Non-Micronized Calcium Carbonate; Dietary Supplement: Vitamin D3 |
| Non-Micronized Calcium Carbonate/Vitamin D3 | Active comparator | 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. Receives: Dietary Supplement: Non-Micronized Calcium Carbonate; Dietary Supplement: Vitamin D3 |
| Micronized Calcium Carbonate/Vitamin D3 | Active comparator | 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 Receives: Dietary Supplement: Micronized Calcium Carbonate; Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 and 183 days
Secondary outcomes (5)
Blood Chemistry Panel
43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein
Measured: 0 and 183 days
Systolic and Diastolic blood pressure
Measures the amount of force (pressure) that blood exerts on the walls of blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study.
Measured: 0 and 183 days
Resting heart rate
Measure of heart rate after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study.
Measured: 0 and 183 days
Self-reported quality of life
Measured: 0 and 183 days
Number of participants with adverse effects
Participants will have opportunity to report on a weekly basis an adverse effects experienced
Measured: up to 183 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia, OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Gilbert R Kaats, Integrative Health Technologies, Inc.
- Investigators
- Gilbert R Kaats, PhD FACN, Principal investigator, Integrative Health Technologies, Inc.Harry G Preuss, MD MACN, Study chair, Georgetown University Medical Center, Dept of Biochemistry, Medicine and PathologySidney J Stohs, PhD, Study director, Dean Emeritus, Creighton University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857154
- Sponsor's protocol ID
- 064
- Status last verified
- Nov 2013
- First submitted
- 8 May 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01857154
- Acronym / sponsor ID
- 064
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- Bone mineral density, Bone mineral content, Bone density, Bone health, Dual-energy x-ray absorptiometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Study start
- May 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3 | Active comparator | Dietary Supplement: Micronized Calcium Carbonate, Dietary Supplement: Vitamin D3Subjects 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 comparator | Dietary Supplement: Non-Micronized Calcium Carbonate, Dietary Supplement: Vitamin D3Subjects 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 comparator | Dietary Supplement: Non-Micronized Calcium Carbonate, Dietary Supplement: Vitamin D3Subjects 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 comparator | Dietary Supplement: Micronized Calcium Carbonate, Dietary Supplement: Vitamin D3Subjects 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized Calcium CarbonateSubjects 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 | Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3, Micronized Calcium Carbonate/Vitamin D3 |
| Non-Micronized Calcium CarbonateSubjects 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 | Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3, Non-Micronized Calcium Carbonate/Vitamin D3 |
| Vitamin D3All subjects in the study cohort will be administered 800 IU Vitamin D3. | Dietary supplement | Bisphosphonates/Micronized Calcium Carbonate/Vitamin D3, Bisphosphonates/Non-Micronized Calcium Carbonate/Vitamin D3, Micronized Calcium Carbonate/Vitamin D3, Non-Micronized Calcium Carbonate/Vitamin D3 |
Primary outcome
Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
Time frame: 0 and 183 days
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
5 secondary outcomes
Blood Chemistry Panel
Time frame: 0 and 183 days
Systolic and Diastolic blood pressure
Time frame: 0 and 183 days
Resting heart rate
Time frame: 0 and 183 days
Self-reported quality of life
Time frame: 0 and 183 days
Number of participants with adverse effects
Time frame: up to 183 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert R Kaats, PhD FACN principal investigator
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN study chair
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
Sidney J Stohs, PhD study director
Dean Emeritus, Creighton University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronized Calcium Carbonate, Non-Micronized Calcium Carbonate and Vitamin D3 in people with Osteopenia, Osteoporosis, run by Integrative Health Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry (time frame: 0 and 183 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.