Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia
Primary Purpose
Calcium, Osteopenia, Bone Mineral Density
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
amorphous calcium carbonate/ Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Calcium
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACC group
control group
Arm Description
ACC group use amorphous calcium carbonate
control group use placebo
Outcomes
Primary Outcome Measures
bone density change
monitoring bone mineral density change and bone turnover markers change
Secondary Outcome Measures
Full Information
NCT ID
NCT05810909
First Posted
March 30, 2023
Last Updated
April 11, 2023
Sponsor
Universal Integrated Corp.
Collaborators
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05810909
Brief Title
Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
September 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universal Integrated Corp.
Collaborators
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcium, Osteopenia, Bone Mineral Density, Bone Turnover Marker
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Placebo-Controlled Parallel-Group Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A Randomized, Double-Blind Trial
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACC group
Arm Type
Experimental
Arm Description
ACC group use amorphous calcium carbonate
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
control group use placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
amorphous calcium carbonate/ Placebo
Intervention Description
The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)
Primary Outcome Measure Information:
Title
bone density change
Description
monitoring bone mineral density change and bone turnover markers change
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal Women
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Wen Chien, professor
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia
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