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

April 11, 2023 updated by: Universal Integrated Corp.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACC group
ACC group use amorphous calcium carbonate
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)
Placebo Comparator: control group
control group use placebo
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universal Integrated Corp.

Collaborators

Taipei Medical University

Investigators

  • Principal Investigator: Yi-Wen Chien, professor, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

September 22, 2022

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Estimate)

April 13, 2023

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201912029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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