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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Integrative Health Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Gilbert R Kaats, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01857154
First received: May 8, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Osteopenia, Osteoporosis
Dietary Supplement: Micronized Calcium Carbonate
Dietary Supplement: Non-Micronized Calcium Carbonate
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Integrative Health Technologies, Inc.:

Primary Outcome Measures:
  • Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry [ Time Frame: 0 and 183 days ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Blood Chemistry Panel [ Time Frame: 0 and 183 days ] [ Designated as safety issue: Yes ]
    43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein

  • Systolic and Diastolic blood pressure [ Time Frame: 0 and 183 days ] [ Designated as safety issue: Yes ]
    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.

  • Resting heart rate [ Time Frame: 0 and 183 days ] [ Designated as safety issue: Yes ]
    Measure of heart rate after lying down for at least 5 minutes. Changes will be reported between baseline and day 183 of study.

  • Self-reported quality of life [ Time Frame: 0 and 183 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse effects [ Time Frame: up to 183 days ] [ Designated as safety issue: Yes ]
    Participants will have opportunity to report on a weekly basis an adverse effects experienced


Estimated Enrollment: 160
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.

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

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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857154

Locations
United States, Texas
Integrative Health Technologies Recruiting
San Antonio, Texas, United States, 78209
Contact: Patricia L Keith, BBA    210-824-4200    hmrcenterstudy@gmail.com   
Contact: Mike Gale    210-824-4200      
Sub-Investigator: Patricia L Keith, BBA         
Sub-Investigator: Samuel C Keith, BBA         
Sub-Investigator: Joel A Michalek, PhD         
Sub-Investigator: Harry A Croft, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Gilbert R Kaats, Dr. Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01857154     History of Changes
Other Study ID Numbers: 064
Study First Received: May 8, 2013
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Health Technologies, Inc.:
Bone mineral density
Bone mineral content
Bone density
Bone health
Dual-energy x-ray absorptiometry

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Cholecalciferol
Diphosphonates
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014