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

Sponsor

Universal Integrated Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT05810909

Collaborator

Taipei Medical University (Other)

Enrollment

Location

Arms

33.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Calcium Osteopenia Bone Mineral Density Bone Turnover Marker	Dietary Supplement: amorphous calcium carbonate/ Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Placebo-Controlled Parallel-Group TrialA Placebo-Controlled Parallel-Group Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

A Randomized, Double-Blind Trial

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 10, 2019

Actual Primary Completion Date :

Dec 10, 2021

Actual Study Completion Date :

Sep 22, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

bone density change [6 months]
monitoring bone mineral density change and bone turnover markers change

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University	Taipei		Taiwan	110

Sponsors and Collaborators

Universal Integrated Corp.
Taipei Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universal Integrated Corp.

ClinicalTrials.gov Identifier:

NCT05810909

Other Study ID Numbers:

N201912029

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Diseases, Metabolic

Calcium Carbonate

Calcium

Study Results

No Results Posted as of Apr 13, 2023