CalciumNCT05810909
Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia
A study of Calcium and Osteopenia, run by Universal Integrated Corp. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Calcium, Osteopenia, Bone Mineral Density
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2019to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).
Who cannot join
- respiratory insufficiency,
- sleep apnea,
- gastroesophageal reflux,
- neurological or liver disease,
- malignant tumor, alcohol abuse,
- hysterectomy or hormonal therapy,
- and depressive symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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".
- Conditions
- Calcium, Osteopenia, Bone Mineral Density, Bone Turnover Marker
- Being tested
- amorphous calcium carbonate/ Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amorphous calcium carbonate/ PlaceboDietary supplement
The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)
| Study group | Role | What they receive |
|---|---|---|
| ACC group | Experimental | ACC group use amorphous calcium carbonate Receives: Dietary Supplement: amorphous calcium carbonate/ Placebo |
| control group | Placebo comparator | control group use placebo Receives: Dietary Supplement: amorphous calcium carbonate/ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone density change
monitoring bone mineral density change and bone turnover markers change
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start10 Dec 2019
- Primary completion10 Dec 2021
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalciumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Placebo-Controlled Parallel-Group Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Integrated Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Yi-Wen Chien, professor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810909
- Sponsor's protocol ID
- N201912029
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05810909
- Acronym / sponsor ID
- N201912029
- Conditions
- Calcium, Osteopenia, Bone Mineral Density, Bone Turnover Marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universal Integrated Corp.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Placebo-Controlled Parallel-Group Trial
| Arm | Type | Receives |
|---|---|---|
| ACC group | Experimental | Dietary Supplement: amorphous calcium carbonate/ PlaceboACC group use amorphous calcium carbonate |
| control group | Placebo comparator | Dietary Supplement: amorphous calcium carbonate/ Placebocontrol group use placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).
Key exclusion criteria (7 listed)
- respiratory insufficiency,
- sleep apnea,
- gastroesophageal reflux,
- neurological or liver disease,
- malignant tumor, alcohol abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amorphous calcium carbonate/ PlaceboThe dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient) | Dietary supplement | ACC group, control group |
Primary outcome
bone density change
Time frame: 6 months
monitoring bone mineral density change and bone turnover markers change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Wen Chien, professor principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Calcium and Osteopenia, run by Universal Integrated Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone density change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.