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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810909
• Other study ID #: N201912029
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: September 22, 2022

Study information

• Verified date: April 2023
• Source: Universal Integrated Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 22, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bone Mineral Density
• Calcium
• Osteopenia

Intervention

Dietary Supplement:
• amorphous calcium carbonate/ Placebo
The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Universal Integrated Corp.	Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone density change	monitoring bone mineral density change and bone turnover markers change	6 months