UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055656 |
|---|---|
| Receipt number | R000063607 |
| Scientific Title | Survey of skin carotenoid density in pregnant women |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2025/09/29 12:24:10 |
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Basic information
Public title
Survey of skin carotenoid density in pregnant women
Acronym
Survey of skin carotenoid density in pregnant women
Scientific Title
Survey of skin carotenoid density in pregnant women
Scientific Title:Acronym
Survey of skin carotenoid density in pregnant women
Region
| Japan |
Condition
Condition
pregnant and postpartum women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the skin carotenoid levels during the period from pregnancy to childbirth
Basic objectives2
Others
Basic objectives -Others
Verification of physiological changes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skin carotenoid levels in early, mid, and late pregnancy, and postpartum
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Mothers who visit the Obstetrics and Perinatal Department of Seirei Hamamatsu General Hospital and wish to give birth in that department.
2. Those who are in singleton pregnancy at the time of participation.
3. Those who wish to participate in this study of their own free will.
4. Those who have provided written consent.
Key exclusion criteria
1. Those who are receiving dietary guidance due to pre-existing conditions.
2. Those who are receiving treatment for mental illnesses.
3. Those deemed ineligible by the attending physician or trial investigator.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Eye center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Kimata |
Organization
Seirei Hamamatsu General Hospital
Division name
Clinical research center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
Homepage URL
https://www.seirei.or.jp/hamamatsu/
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Akira Obana
Funding Source
Organization
Seirei Hamamatsu General Hospital
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
Clinical Research Center, Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
0534742222
m-kimata@sis.seirei.or.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
総合病院聖隷浜松病院産科・周産期科
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 31 | 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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In longitudinal study participants, skin carotenoids will be measured in early, mid, and late pregnancy, as well as postpartum. In cross-sectional study participants, skin carotenoids will be measured at a single time point.
Management information
Registered date
| 2024 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063607
