UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057942 |
|---|---|
| Receipt number | R000066228 |
| Scientific Title | Effects of Eggshell Calcium Supplementation on Blood Pressure |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/08/13 00:27:16 |
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Basic information
Public title
Effects of Eggshell Calcium Supplementation on Blood Pressure in Vietnamese Women with High Risk of Hypertension
Acronym
Effects of Eggshell Calcium Supplementation on Blood Pressure
Scientific Title
Effects of Eggshell Calcium Supplementation on Blood Pressure
Scientific Title:Acronym
Effects of Eggshell Calcium Supplementation on Blood Pressure
Region
| Asia(except Japan) |
Condition
Condition
mildly hypertensive women
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigated the effect of eggshell calcium intake on blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decrease in SBP and DBP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Egg Shell Supplement
Interventions/Control_2
Contriol Supplement
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Systolic >130 mmHg or diastole blood pressure >90 mmHg, have a calcium intake less than >300 mg
2) Subjects who are able to participate in the study for 6 month
3) Subjects who give the written informed consent.
Key exclusion criteria
1) Those who are on a special diet
2) Pregnant and lactating women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamamoto |
Organization
Jumonji University
Division name
Asian Nutrition and Food Culture Research Center
Zip code
352-8510
Address
2-1-28, Sugasawa, Niiza, Saitama
TEL
048-260-7613
shigeruy@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
R&D Division
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
ryosuke_matsuoka@kewpie.co.jp
Sponsor or person
Institute
National Institute of Nutrition, Vietnam
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
National Institute of Nutrition, Vietnam
Address
48B Tang Bat Ho Street, Hanoi
Tel
842439710576
hienvuthithu.nin@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 23 | 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
100
Results
The decrease in SBP and DBP in the eggshell Ca group was significantly greater than that in the control group.
Results date posted
| 2025 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066228
