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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

160

Phase

  • 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

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
Intervention / Treatment
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

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

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

Integrative Health Technologies, Inc.

Investigators

  • 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

May 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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