NCT05810909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 30, 2023

Last Update Submit

April 11, 2023

Conditions

CalciumOsteopeniaBone Mineral DensityBone Turnover Marker

Outcome Measures

Primary Outcomes (1)

  • bone density change

    monitoring bone mineral density change and bone turnover markers change

    6 months

Study Arms (2)

ACC group

EXPERIMENTAL

ACC group use amorphous calcium carbonate

Dietary Supplement: amorphous calcium carbonate/ Placebo

control group

PLACEBO COMPARATOR

control group use placebo

Dietary Supplement: amorphous calcium carbonate/ Placebo

Interventions

amorphous calcium carbonate/ PlaceboDIETARY_SUPPLEMENT

The dosage was 1000 mg calcium carbonate (400mg calcium element) per day, and placebo (calcium carbonate change to excipient)

ACC groupcontrol group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal Women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).

You may not qualify if:

  • respiratory insufficiency,
  • sleep apnea,
  • gastroesophageal reflux,
  • neurological or liver disease,
  • malignant tumor, alcohol abuse,
  • hysterectomy or hormonal therapy,
  • and depressive symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yi-Wen Chien, professor

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A Randomized, Double-Blind Trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Placebo-Controlled Parallel-Group Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 13, 2023

Study Start

December 10, 2019

Primary Completion

December 10, 2021

Study Completion

September 22, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)