UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058440 |
|---|---|
| Receipt number | R000066798 |
| Scientific Title | The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women |
| Date of disclosure of the study information | 2025/07/14 |
| Last modified on | 2025/07/12 12:57:43 |
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Basic information
Public title
The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women
Acronym
The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women
Scientific Title
The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women
Scientific Title:Acronym
The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women
Region
| Japan |
Condition
Condition
Vitamin D insufficiency and deficiency
Classification by specialty
| Medicine in general | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect of individualized health guidance on increasing serum vitamin D concentrations in young women with insufficient or deficient serum vitamin D levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum vitamin D
Key secondary outcomes
An increase in vitamin D intake, dietary fat intake, and sun exposure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
For individuals with insufficient vitamin D intake, health guidance will be provided to increase vitamin D intake, followed by supplementation with a commercially available vitamin D supplement (25 ug per capsule per day) for 80 days.
For individuals with insufficient fat intake, health guidance will be provided to increase fat intake, followed by supplementation with a commercially available mixed nuts snack (6.0 g per pack), taken four days per week for 80 days.
For individuals with insufficient ultraviolet (UV) exposure, health guidance will be provided on safe UV exposure methods to increase vitamin D levels while minimizing potential risks.
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
| 19 | years-old | >= |
Gender
Female
Key inclusion criteria
The participants in this study will be first-year undergraduate nursing students recruited through convenience sampling, who have provided informed consent and have serum 25(OH) vitamin D levels below 30 ng/mL.
Key exclusion criteria
Individuals with diseases that affect nutrient absorption, such as those with conditions damaging the small intestinal mucosa (e.g., Crohn's disease), those who have undergone extensive small intestine resection, or those with diseases causing lymphatic obstruction (e.g., intestinal lymphangiectasia)
Individuals with liver or kidney disorders affecting vitamin D metabolism
Individuals with a bleeding tendency, such as those with a history of difficulty stopping bleeding after blood collection or those taking anticoagulant medications
Individuals with allergies to apples, gelatin, or nuts
Individuals with skin damage or lesions
Individuals with photosensitivity
Individuals with anxiety about self-blood collection
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | honoka |
| Middle name | |
| Last name | seki |
Organization
Doshisha Women's College of Liberal Arts, Graduate School
Division name
Graduate School of Nursing, Department of Nursing
Zip code
6100395
Address
Kodo,Kyotanabe City,Kyoto
TEL
0774-65-8631
ik24006@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | honoka |
| Middle name | |
| Last name | seki |
Organization
Doshisha Women's College of Liberal Arts, Graduate School
Division name
Graduate School of Nursing, Department of Nursing
Zip code
6100395
Address
Kodo,Kyotanabe City,Kyoto
TEL
0774-65-8631
Homepage URL
ik24006@dwc.doshisha.ac.jp
Sponsor or person
Institute
Doshisha Women's College of Liberal Arts, Graduate School
Institute
Department
Personal name
seki honoka
Funding Source
Organization
none
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
Research Support Section, Academic Information Division, Doshisha Womens College of Liberal Arts
Address
97-1 Minamihotate, Kodo, Kyotanabe-shi, Kyoto 610-0395, Japan
Tel
0774-65-8679
research@dwc.doshisha.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
| 2025 | Year | 07 | Month | 14 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | 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
Management information
Registered date
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | 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=R000066798
