Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia

Study Overview
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Brief Summary
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This research was designed in accordance to the Method for Efficacy Assessment of Health Food for Bone Heath. Changes to bone density were measured to evaluate the effectiveness of amorphous calcium carbonate in maintaining bone health.

Detailed Description
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Bone comprises organic matter, predominantly protein, and inorganic matter including various mineral salts. Inappropriate nutrition profile can affect the balance of bone metabolism and cause bone loss. Of all nutrients, calcium is considered the most important for bone structure and metabolism. It is the most common deficit that affects bone health. Low dietary calcium intake can lead to negative calcium balance. Low blood calcium (< 10mg/dL) induces the release of parathyroid hormone (PTH), which activates the conversion process of 25-(OH)-D3 to physiologically active 1,25-(OH)2-D3 in kidneys. PTH and 1,25-(OH)2-D3 act jointly to change the ionic valence of hydroxyapatite, converting orthophosphate to pyrophosphate. This causes hydroxyapatite to easily dissociate and release calcium ion in order to compensate the blood calcium level. This is called bone resorption. While this physiological mechanism maintains blood calcium homeostasis, it also causes bone loss that can develop into osteoporosis. Negative calcium balance is not only caused by lack of dietary calcium, hormonal abnormality or vitamin D deficit may also lead to negative calcium balance and the development of osteoporosis. This study aims to assess the effects of UIC Amorphous Calcium on osteoporosis with Bone Change Test and Calcium Bioavailability Test.

Official Title
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Effects of Amorphous Calcium Carbonate Supplementation on Bone Health Based on Bone Mineral Density and Bone Turno-ver Markers: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Trial in Postmenopausal Women With Osteopenia

Conditions
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Calcium, Osteopenia, Bone Mineral Density, Bone Turnover Marker

Intervention / Treatment
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* Dietary Supplement: amorphous calcium carbonate/ Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred). Exclusion Criteria: respiratory insufficiency, sleep apnea, gastroesophageal reflux, neurological or liver disease, malignant tumor, alcohol abuse, hysterectomy or hormonal therapy, and depressive symptoms.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Placebo-Controlled Parallel-Group Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACC group<br>ACC group use amorphous calcium carbonate | Dietary Supplement: amorphous calcium carbonate/ Placebo<br>* The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)<br>|
| Placebo Comparator: control group<br>control group use placebo | Dietary Supplement: amorphous calcium carbonate/ Placebo<br>* The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density change | monitoring bone mineral density change and bone turnover markers change | 6 months |