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
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Micronized Calcium Carbonate (Dietary Supplement)
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.
干预措施: Non-Micronized Calcium Carbonate (Dietary Supplement)
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.
干预措施: Non-Micronized Calcium Carbonate (Dietary Supplement)
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
干预措施: Micronized Calcium Carbonate (Dietary Supplement)
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.
干预措施: Vitamin D3 (Dietary Supplement)
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.
干预措施: Vitamin D3 (Dietary Supplement)
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
干预措施: Vitamin D3 (Dietary Supplement)
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
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
时间窗: 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
次要结局
- Self-reported quality of life(0 and 183 days)
- Systolic and Diastolic blood pressure(0 and 183 days)
- Blood Chemistry Panel(0 and 183 days)
- Resting heart rate(0 and 183 days)
- Number of participants with adverse effects(up to 183 days)
研究者
Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
Integrative Health Technologies, Inc.