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

November 21, 2013 updated by: Gilbert R Kaats, Integrative Health Technologies, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Integrative Health Technologies
        • Contact:
        • Sub-Investigator:
          • Patricia L Keith, BBA
        • Sub-Investigator:
          • Samuel C Keith, BBA
        • Contact:
          • Mike Gale
          • Phone Number: 210-824-4200
        • Sub-Investigator:
          • Joel A Michalek, PhD
        • Sub-Investigator:
          • Harry A Croft, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Dietary supplement: 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.

Dietary supplement: Vitamin D3
All subjects in the study cohort will be administered 800 IU Vitamin D3.
Active Comparator: 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.
Dietary supplement: Vitamin D3
All subjects in the study cohort will be administered 800 IU Vitamin D3.
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.
Active Comparator: 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.
Dietary supplement: Vitamin D3
All subjects in the study cohort will be administered 800 IU Vitamin D3.
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.
Active Comparator: 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
Dietary supplement: 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
0 and 183 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Chemistry Panel
Time Frame: 0 and 183 days
43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein
0 and 183 days
Systolic and Diastolic blood pressure
Time Frame: 0 and 183 days
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.
0 and 183 days
Resting heart rate
Time Frame: 0 and 183 days
Measure of heart rate after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study.
0 and 183 days
Self-reported quality of life
Time Frame: 0 and 183 days
0 and 183 days
Number of participants with adverse effects
Time Frame: up to 183 days
Participants will have opportunity to report on a weekly basis an adverse effects experienced
up to 183 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integrative Health Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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