UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062989 |
|---|---|
| Receipt number | R000072003 |
| Scientific Title | Effects of improvement in vitamin D nutritional status on health outcomes in middle-aged and older women: a randomized three-arm parallel-group trial combining exercise and vitamin D supplementation (Study I) |
| Date of disclosure of the study information | 2026/09/19 |
| Last modified on | 2026/09/19 01:44:23 |
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Basic information
Public title
A comparative trial of vitamin D supplementation and exercise on health outcomes in middle-aged and older women
Acronym
Vitamin D and Exercise Trial in Women
Scientific Title
Effects of improvement in vitamin D nutritional status on health outcomes in middle-aged and older women: a randomized three-arm parallel-group trial combining exercise and vitamin D supplementation (Study I)
Scientific Title:Acronym
Vitamin D and Exercise RCT in Women, Study I
Region
| Japan |
Condition
Condition
Risk of vitamin D insufficiency or deficiency, bone and calcium metabolism, and health status related to frailty and locomotive syndrome prevention
Classification by specialty
| Geriatrics | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of vitamin D supplementation at 50ug/day (2,000 IU/day), alone or in combination with exercise, on serum 25-hydroxyvitamin D [25(OH)D], serum calcium, whole parathyroid hormone (PTH), and bone turnover markers among community-dwelling middle-aged and older women during the autumn-winter season. Secondary objectives are to explore the effects on muscle strength, physical function, bone density, neuromuscular function, self-reported health status, sleep, skin condition, common cold symptoms, and pain-related outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes from baseline to 3 months after the intervention in the following outcomes:
1. Calcium metabolism markers: serum 25-hydroxyvitamin D [25(OH)D], serum calcium, serum whole parathyroid hormone (PTH), and composite balance indices based on these markers
2. Bone turnover markers: serum TRACP-5b, serum P1NP, and composite balance indices based on these markers
Key secondary outcomes
Changes from baseline to 3 months after the intervention in the following outcomes:
1. Bone density indices: speed of sound (SOS) and stiffness index measured by calcaneal ultrasound
2. Muscle strength and physical function: grip strength, five-times chair stand test, usual and maximum walking speed, locomotive syndrome tests, and the 25-question Geriatric Locomotive Function Scale
3. Neuromuscular function: gait stability and postural sway
4. Self-reported health-related outcomes: common cold symptoms, urinary symptoms, skin condition, sleep quality, shoulder pain, and low back pain
5. Intervention adherence: attendance at exercise classes, achievement of home-based training, adherence to study food intake, and changes in step counts
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Group A, vitamin D supplementation alone: No exercise instruction. Participants will take an active study tablet containing vitamin D 50 ug/day (2,000 IU/day) for 3 months.
Interventions/Control_2
Group B, exercise alone: Participants will attend a supervised exercise class once weekly for 75 minutes, 12 sessions in total, and take a placebo tablet for 3 months. The exercise program consists of stretching, resistance exercise, aerobic exercise, and coordination exercise with progressive intensity increased every 2 weeks under the supervision of physical therapists.
Interventions/Control_3
Group C, exercise plus vitamin D supplementation: Participants will attend a supervised exercise class once weekly for 75 minutes, 12 sessions in total, and take an active study tablet containing vitamin D 50ug/day (2,000 IU/day) for 3 months.
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Women aged 40 to 79 years as of March 31, 2027
2. Not receiving strict dietary guidance from a physician or other health professional
3. Not engaging in regular moderate or higher intensity exercise at least twice per week
4. Not regularly taking supplements for osteoporosis prevention containing vitamin D
5. Not currently receiving treatment for osteoporosis, diabetes mellitus, chronic kidney disease, thyroid disease, or related conditions
6. Able to provide written informed consent
Key exclusion criteria
1. Individuals judged unable to continue the 3-month intervention program
2. Individuals with safety concerns regarding intake of the study food, participation in exercise classes, blood or urine sampling, or physical function measurements
3. Individuals judged by the principal investigator or co-investigators to be inappropriate for participation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Shinkai |
Organization
Japan Nutrition University
Division name
Shinkai Laboratory
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakado-city, Saitama
TEL
+81-49-282-4791
shinkai.shoji@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Shinkai |
Organization
Japan Nutrition University
Division name
Shinkai Laboratory
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakado-city, Saitama
TEL
+81-49-282-4791
Homepage URL
shinkai.shoji@eiyo.ac.jp
Sponsor or person
Institute
Japan Nutrition University
Institute
Department
Personal name
Shoji Shinkai
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saitama Medical University
Otsuka Pharmaceutical Co., Ltd.
Ina Hospital
Yamagata University
Tokyo Online University
Name of secondary funder(s)
None.
IRB Contact (For public release)
Organization
Japan Nutrition University Research Support Division
Address
3-9-21, Chiyoda, Sakado-city, Saitama
Tel
+81-49-282-1353
kenshien@eiyo.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
日本栄養大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 19 | 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 | 15 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary analysis of primary outcomes will be performed using a mixed model for repeated measures (MMRM) in the full analysis set or an intention-to-treat-like analysis population. The model will include group, time, and group-by-time interaction, with adjustment for age strata and other relevant covariates as appropriate. Between-group differences at 3 months, or differences in change from baseline based on the group-by-time interaction, will be estimated as least-squares mean differences with 95% confidence intervals and nominal p-values.
Sensitivity analyses will include ANCOVA with the post-intervention value as the dependent variable and treatment group, baseline value, and age strata as explanatory variables, as well as analyses in a prespecified per-protocol set. Log transformation will be considered for skewed continuous outcomes, and non-parametric tests will be used as supplementary analyses when model assumptions are substantially violated. Binary and count outcomes will be analyzed using logistic regression, negative binomial regression, or generalized linear mixed models, as appropriate.
Because this is an exploratory study, results will be interpreted primarily based on effect sizes, 95% confidence intervals, and nominal p-values.
Management information
Registered date
| 2026 | Year | 09 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072003
