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

Not Applicable

Completed

• Conditions: Calcium; Osteopenia; Bone Turnover Marker; Bone Mineral Density
• Interventions: Dietary Supplement: amorphous calcium carbonate/ Placebo

• Registration Number: NCT05810909
• Lead Sponsor: Universal Integrated Corp.

Brief Summary

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

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".

Study Timeline

• Study Start: 2019-12-10
• Primary Completion: 2021-12-10
• Study Completion: 2022-09-22
• Study First Submitted: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACC group	amorphous calcium carbonate/ Placebo	ACC group use amorphous calcium carbonate
control group	amorphous calcium carbonate/ Placebo	control group use placebo

Primary Outcome Measures

Name	Time	Method
bone density change	6 months	monitoring bone mineral density change and bone turnover markers change

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan