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

Universal Integrated

Status: Completed

Conditions: Osteopenia; Bone Mineral Density; Bone Turnover Marker; Calcium

Treatments: Dietary Supplement: amorphous calcium carbonate/ Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05810909

N201912029

Details and patient eligibility

About

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.

Full description

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".

Enrollment: 35 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

ACC group

Experimental group

Description:

ACC group use amorphous calcium carbonate

Treatment:

Dietary Supplement: amorphous calcium carbonate/ Placebo

control group

Placebo Comparator group

Description:

control group use placebo

Treatment:

Dietary Supplement: amorphous calcium carbonate/ Placebo