UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058127 |
|---|---|
| Receipt number | R000066440 |
| Scientific Title | Clinical trial comparing blood vitamin D concentrations by dosage form of vitamin D supplements |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/09 14:05:21 |
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Basic information
Public title
Clinical trial comparing blood vitamin D concentrations by dosage form of vitamin D supplements
Acronym
Comparative clinical trial of different forms of vitamin D supplements
Scientific Title
Clinical trial comparing blood vitamin D concentrations by dosage form of vitamin D supplements
Scientific Title:Acronym
Comparative clinical trial of different forms of vitamin D supplements
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare post-ingestion serum 25-hydroxyvitamin D [25(OH)D] concentrations among three supplement dosage forms (tablet, soft gel capsule, and highly dispersible capsule) and to identify the dosage form with the highest absorption efficiency.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean increase in 25-hydroxyvitamin D [25(OH)D] levels calculated from pre- and post-supplementation blood measurements
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eligible study participants will be equally divided into three groups (Group I: tablet, Group II: soft gel capsule, Group III: highly dispersible capsule). Each group will take a single tablet (1,000 IU) of their assigned vitamin D supplement once daily after dinner for one week. Blood sampling (4 mL) will be conducted before and after supplementation to measure serum 25-hydroxyvitamin D [25(OH)D] levels. This comparative trial among the three groups will be used to identify the dosage form with the highest absorption efficiency. Allocation will be performed as follows: after obtaining consent by the principal investigator, research associates will confirm eligibility, register participants, and assign them to Group I, Group II, or Group III in that order.
Interventions/Control_2
Eligible study participants will be equally divided into three groups (Group I: tablet, Group II: soft gel capsule, Group III: highly dispersible capsule). Each group will take a single tablet (1,000 IU) of their assigned vitamin D supplement once daily after dinner for one week. Blood sampling (4 mL) will be conducted before and after supplementation to measure serum 25-hydroxyvitamin D [25(OH)D] levels. This comparative trial among the three groups will be used to identify the dosage form with the highest absorption efficiency. Allocation will be performed as follows: after obtaining consent by the principal investigator, research associates will confirm eligibility, register participants, and assign them to Group I, Group II, or Group III in that order.
Interventions/Control_3
Eligible study participants will be equally divided into three groups (Group I: tablet, Group II: soft gel capsule, Group III: highly dispersible capsule). Each group will take a single tablet (1,000 IU) of their assigned vitamin D supplement once daily after dinner for one week. Blood sampling (4 mL) will be conducted before and after supplementation to measure serum 25-hydroxyvitamin D [25(OH)D] levels. This comparative trial among the three groups will be used to identify the dosage form with the highest absorption efficiency. Allocation will be performed as follows: after obtaining consent by the principal investigator, research associates will confirm eligibility, register participants, and assign them to Group I, Group II, or Group III in that order.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female participants aged 20 years or older but younger than 50 years at the time of consent.
2. Body mass index (BMI) between 18.5 and 29.9.
3. No excessive tanning, such as through tanning salons.
4. Individuals who, after receiving sufficient explanation about the study and fully understanding the content, provided written informed consent based on their own free will.
Key exclusion criteria
1. Individuals who had taken vitamin D or a multivitamin supplement containing vitamin D at least once per week during the past five months.
2. Individuals who had traveled to regions with strong sunlight in the past three months or who planned to do so during the study period.
3. Individuals with a history of malabsorption syndrome or irritable bowel syndrome.
4. Individuals judged by the principal investigator to be unsuitable for participation in the study for any other reason.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
Juntendo University Fuculty of Medicine
Division name
Food and Reproductive Function Advanced Research
Zip code
113-8421
Address
2-1-1 Hongo Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
k.kawamura.aq@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kawamura |
Organization
Juntendo University Fuculty of Medicine
Division name
Food and Reproductive Function Advanced Research
Zip code
113-8421
Address
2-1-1 Hongo Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
k.kawamura.aq@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Partners
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee
Address
2-1-1 Hongo Bunkyoku, Tokyo, Japan
Tel
03-3813-3111
igakubu.rinri1@juntendo.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 | 06 | Month | 09 | 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
| 2025 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066440
