UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057040 |
|---|---|
| Receipt number | R000064769 |
| Scientific Title | The Effect of Enhanced Vitamin D Intake on the Improvement of Activities of Daily Living in Rehabilitation Patients with Sarcopenia Following Vertebral Compression Fracture |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2026/01/23 09:13:51 |
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Basic information
Public title
The Effect of Enhanced Vitamin D Intake on the Improvement of Activities of Daily Living in Rehabilitation Patients with Sarcopenia Following Vertebral Compression Fracture
Acronym
The Effect of Enhanced Vitamin D Intake on the Improvement of Activities of Daily Living in Rehabilitation Patients with Sarcopenia Following Vertebral Compression Fracture
Scientific Title
The Effect of Enhanced Vitamin D Intake on the Improvement of Activities of Daily Living in Rehabilitation Patients with Sarcopenia Following Vertebral Compression Fracture
Scientific Title:Acronym
The Effect of Enhanced Vitamin D Intake on the Improvement of Activities of Daily Living in Rehabilitation Patients with Sarcopenia Following Vertebral Compression Fracture
Region
| Japan |
Condition
Condition
Vertebral compression fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of enhanced vitamin D intake on the improvement of activities of daily living (ADL) in elderly rehabilitation patients with vertebral compression fractures who exhibit sarcopenia and vitamin D deficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL at the end of the intervention: To be evaluated using the Barthel Index score six weeks after randomization.
The evaluation of patients discharged early will be conducted via a telephone survey 6 weeks after randomization.
Key secondary outcomes
At the end of the intervention (at six weeks post-randomization): Skeletal Muscle mass Index, Phase Angle, Grip Strength, Gait Speed, Short Physical Performance Battery Score, Tongue Pressure, Serum 25-Hydroxyvitamin D [25(OH)D] Level, Pain Severity (Numerical Rating Scale)
ADL three months after the completion of the intervention: To be assessed using the Barthel Index score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Daily consumption of one cup of juice fortified with vitamin D supplements (2000 IU) for six weeks
Interventions/Control_2
Daily consumption of one cup of juice without vitamin D fortification
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women aged 65 years or older at the time of admission.
Hospitalized for rehabilitation following vertebral compression fractures: thoracic or lumbar vertebral fractures.
Vitamin D deficiency: Serum 25-hydroxyvitamin D less than 30 nanograms per milliliter at admission
Presence of Sarcopenia: Assessed at the time of admission based on the definition by the Asian Working Group for Sarcopenia 2019 (characterized by reduced muscle strength or physical performance, along with decreased skeletal muscle mass).
Barthel Index walking score less than or equal to 10 at admission.
During the baseline evaluation period, dietary energy intake meets at least 80% of the required nutritional intake.
Key exclusion criteria
Mini-Mental State Examination MMSE score less than 10 at the time of admission.
Use of implantable devices such as pacemakers.
Conditions that make nutritional interventions difficult such as allergies to vitamin D or dairy products.
Use of other nutritional supplements calcium preparations or medications related to vitamin D.
Expected to be discharged within one month of admission.
Body Mass Index BMI greater than or equal to 25.
Presence of the following diseases that may cause adverse effects from nutritional interventions.
Kidney disease estimated glomerular filtration rate less than 30 mL per min
Thyroid disorders
Hypercalcemia
Active cancer
Liver dysfunction Child-Pugh class B or C
Inability to perform resistance exercises due to weight-bearing restrictions.
Requiring long-term care level 4 or 5 prior to the current vertebral compression fracture.
Paralysis of the limbs or neuromuscular diseases.
Inability to obtain oral nutritional intake due to dysphagia.
Presence of severe or unstable medical conditions.
Participation in other clinical trials.
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Kotomi |
| Middle name | |
| Last name | Sakai |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Department of Research
Zip code
151-0053
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo
TEL
03-6712-6401
sakai.kotomi@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Kotomi |
| Middle name | |
| Last name | Sakai |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Department of Research
Zip code
151-0053
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo
TEL
03-6712-640
Homepage URL
sakai.kotomi@hmw.gr.jp
Sponsor or person
Institute
Department of Research, Heisei Medical Welfare Group Research Institute
Institute
Department
Personal name
Funding Source
Organization
Heisei Medical Welfare Group Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Heisei Medical Welfare Group Research Institute
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo
Tel
03-6712-6401
info.research@hmw.gr.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 | 03 | Month | 12 | 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
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 01 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064769
