An interventional study of Micronized Calcium Carbonate and Non-Micronized Calcium Carbonate in Osteopenia, Osteoporosis, sponsored by Integrative Health Technologies, Inc.. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-25.
Sponsored by Integrative Health Technologies, Inc. · Not applicable and Interventional
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.
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's planned enrollment of 160 is above the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Integrative Health Technologies, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 · Dietary Supplement: 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 · Dietary Supplement: 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 · Dietary Supplement: 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 · Dietary Supplement: Vitamin D3
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.
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
Time frame: 0 and 183 days
Blood Chemistry Panel
43 chemistries including lipids, Complete Blood Count, metabolic panel, Thyroid Stimulating Hormone and Cardio C-reactive Protein
Time frame: 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.
Time frame: 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.
Time frame: 0 and 183 days
Self-reported quality of life
Time frame: 0 and 183 days
Number of participants with adverse effects
Participants will have opportunity to report on a weekly basis an adverse effects experienced
Time frame: up to 183 days
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium Carbonate
Integrative Health Technologies, Inc.