Clinical trial NCT05810909: 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
Overall status: COMPLETED
Phase: NA
Conditions: Calcium
Osteopenia
Bone Mineral Density
Bone Turnover Marker
Lead sponsor: Universal Integrated Corp.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University
First posted: 2023-04-13
Enrollment: 35
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Placebo-Controlled Parallel-Group Trial
Primary purpose: PREVENTION

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".

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.

Primary outcomes:
measure: bone density change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Yi-Wen Chien, professor
role: PRINCIPAL_INVESTIGATOR
References: