UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062214 |
|---|---|
| Receipt number | R000071187 |
| Scientific Title | Effect of Sun-Dried Dried Squid Products (Sakiika) on Vitamin D Status: Evaluation Using Blood and Urinary Biomarkers |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/07/12 11:41:37 |
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Basic information
Public title
Effect of Sun-Dried Dried Squid Products (Sakiika) on Vitamin D Status
Acronym
Effect of Sun-Dried Dried Squid Products on Vitamin D Status
Scientific Title
Effect of Sun-Dried Dried Squid Products (Sakiika) on Vitamin D Status: Evaluation Using Blood and Urinary Biomarkers
Scientific Title:Acronym
Effect of Sun-Dried Dried Squid Products (Sakiika) on Vitamin D Status
Region
| Japan |
Condition
Condition
Vitamin D deficiency and insufficiency
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to determine whether sun-dried sakiika (dried squid) can improve vitamin D status in individuals with vitamin D deficiency or insufficiency and thereby serve as a practical dietary option for improving vitamin D nutritional status. In addition, this study aims to evaluate whether urinary 25-hydroxyvitamin D [25(OH)D] concentration, measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS), can be used as a biomarker of vitamin D nutritional status in addition to the conventional assessment based on serum 25(OH)D concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum and urinary 25-hydroxyvitamin D [25(OH)D] concentrations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group: Participants will consume sun-dried sakiika (dried squid) four times per week for 4 weeks.
Interventions/Control_2
Control group: Participants will consume sakiika (dried squid) that has not been sun-dried four times per week for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy women in their 20s and 30s who provide written informed consent to participate in this study at Kobe Gakuin University.
Key exclusion criteria
Individuals with a past or current history of severe hepatic or renal disease, autoimmune disease, diabetes mellitus, dyslipidemia, metabolic syndrome, hypolipidemia, thyroid disease, bone metabolic disorders, or any other condition requiring medical treatment, as well as those taking dietary supplements, will be excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Tsugawa |
Organization
Kobe Gakuin University
Division name
Faculty of Nutrition
Zip code
651-2180
Address
518,Arise, Ikawadani-cho, Nichi-ku, Kobe 651-2180, Hyogo, Japan
TEL
078-974-4998
tsugawa@nutr.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Tsugawa |
Organization
Kobe Gakuin University
Division name
Faculty of Nutrition
Zip code
651-2180
Address
518,Arise, Ikawadani-cho, Nichi-ku, Kobe 651-2180, Hyogo, Japan
TEL
078-974-4998
Homepage URL
tsugawa@nutr.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Sysmex BioMajesty Co.,Ltd.
IRB Contact (For public release)
Organization
Research Ethics Committee for Life Sciences and Medical Research, Kobe Gakuin University
Address
518,Arise, Ikawadani-cho, Nichi-ku, Kobe 651-2180, Hyogo, Japan
Tel
078-974-4297
kenkyu@j.kobegakuin.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071187
