UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056776 |
|---|---|
| Receipt number | R000064899 |
| Scientific Title | Test of the Improvement in Bone Density and Secondary Effects of Hydrogen Coral Powder Supplements in Pre-Osteoporosis Cases |
| Date of disclosure of the study information | 2025/01/22 |
| Last modified on | 2025/01/22 01:01:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Test of the Improvement in Bone Density and Secondary Effects of Hydrogen Coral Powder Supplements in Pre-Osteoporosis Cases
Acronym
Test of the Effects of Hydrogen Coral Powder Supplements on Pre-Osteoporosis Cases
Scientific Title
Test of the Improvement in Bone Density and Secondary Effects of Hydrogen Coral Powder Supplements in Pre-Osteoporosis Cases
Scientific Title:Acronym
Test of the Effects of Hydrogen Coral Powder Supplements on Pre-Osteoporosis Cases
Region
| Japan |
Condition
Condition
Women aged 40 to 75 with pre-osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in bone density and blood test results, women with pre-osteoporosis were instructed to take five capsules of hydrogen coral powder supplements daily, divided into two doses in the morning and evening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone density (femur and lumbar spine)
Key secondary outcomes
Blood tests, body composition measurements (height, weight, muscle mass, etc.), and skin frailty-related tests
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take five capsules of hydrogen coral powder supplements daily, divided into two doses in the morning and evening
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Pe-osteoporosis
Key exclusion criteria
If the attending physician determines that participation in the trial is inappropriate.
History of fractures caused by osteoporosis.
Severe diabetes, hypertension, etc.
Presence of thyroid disease.
Currently taking calcium channel blockers.
Due to hypercalcemia as a side effect of vitamin D, blood vitamin D levels and blood calcium levels should be measured and considered.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yano |
Organization
First Co.,Ltd.
Division name
Clinical Operations Division
Zip code
141-0001
Address
Rm1008, Kitashinagawa 5-7-14, Shinagawa-ku, Tokyo
TEL
03-5475-8967
info@suiso1st.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yano |
Organization
First Co.,Ltd.
Division name
Clinical Operations Division
Zip code
141-0001
Address
Rm1008, Kitashinagawa 5-7-14, Shinagawa-ku, Tokyo
TEL
03-5475-8967
Homepage URL
info@suiso1st.co.jp
Sponsor or person
Institute
Meguro Komazawa Lihabilitation Orthopedic Clinic
Institute
Department
Personal name
Funding Source
Organization
First Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
First Co.,Ltd.
Address
Rm1008, Kitashinagawa 5-7-14, Shinagawa-ku, Tokyo
Tel
03-5475-8967
info@suiso1st.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
目黒駒沢リハビリ整形外科クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064899
