UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060022 |
|---|---|
| Receipt number | R000068647 |
| Scientific Title | A Double-Blind Randomized Controlled Trial to Evaluate the Effect of a Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/09 09:44:39 |
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Basic information
Public title
Effect of Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures: A Double-Blind Randomized Controlled Trial
Acronym
Effect of Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures: A Double-Blind Randomized Controlled Trial
Scientific Title
A Double-Blind Randomized Controlled Trial to Evaluate the Effect of a Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures
Scientific Title:Acronym
VD-FF Trial
Region
| Japan |
Condition
Condition
Hip fracture or vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the intake of a vitamin D-fortified milk beverage improves serum 25(OH)D levels in patients with proximal femoral or vertebral fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum 25(OH)D levels from admission to discharge.
Key secondary outcomes
1. Improvement rate of vitamin D deficiency (proportion of patients with serum 25(OH)D >= 20 ng/mL at discharge)
2. Serum 25(OH)D level at discharge
3. Changes in Functional Independence Measure (FIM) scores
4. Change in Skeletal Muscle Mass Index (SMI)
5. Incidence of adverse events, defined as decreased renal function (eGFR < 60 mL/min/1.73m2) or hypercalcemia (serum calcium >= 10.5 mg/dL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A vitamin D-fortified milk beverage containing 9.0 micrograms of vitamin D per bottle will be provided once daily at breakfast from admission to discharge.
Interventions/Control_2
A milk beverage without vitamin D will be provided once daily at breakfast from admission to discharge.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted with proximal femoral fracture or vertebral fracture
2. Patients or their representatives who provide written informed consent
Key exclusion criteria
1. Patients with contraindications to dairy products (such as allergy or intolerance)
2. Patients with severe swallowing disorders that make oral intake of the milk beverages difficult
3. Patients judged by the attending physician to be medically unsuitable for participation
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Araki |
| Middle name | |
| Last name | Saito |
Organization
Yoshida Hospital
Division name
Department of Nutrition
Zip code
940-0053
Address
1-1668 Naga-cho, Nagaoka, Niigata, Japan
TEL
0258-32-0490
araki.saito0527@gmail.com
Public contact
Name of contact person
| 1st name | Araki |
| Middle name | |
| Last name | Saito |
Organization
Yoshida Hospital
Division name
Department of Nutrition
Zip code
940-0053
Address
1-1668 Naga-cho, Nagaoka, Niigata, Japan
TEL
0258-32-0490
Homepage URL
araki.saito0527@gmail.com
Sponsor or person
Institute
Yoshida Hospital
Institute
Department
Personal name
Funding Source
Organization
Koisumi Foundation
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
Nagaoka Central General Hospital Ethics Committee
Address
2041 Kawasaki-machi, Nagaoka-shi, Niigata, Japan
Tel
0258-35-3700
iriyousienka@nagachu.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 | 12 | Month | 15 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2027 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068647
