UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055613 |
|---|---|
| Receipt number | R000063547 |
| Scientific Title | The impact of consuming vitamin D-fortified drinks on the treatment of patients with fractures |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/12/09 10:59:50 |
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Basic information
Public title
The impact of consuming vitamin D-fortified drinks on the treatment of patients with fractures
Acronym
The impact of consuming vitamin D-fortified drinks on the treatment of patients with fractures
Scientific Title
The impact of consuming vitamin D-fortified drinks on the treatment of patients with fractures
Scientific Title:Acronym
The impact of consuming vitamin D-fortified drinks on the treatment of patients with fractures
Region
| Japan |
Condition
Condition
Postoperative patient with proximal femoral fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate that the consumption of vitamin D-fortified milk beverages allows for effective vitamin D intake. Additionally, this study will investigate the effects of vitamin D intake on serum 25(OH)D levels and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum 25-hydroxyvitamin D
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to a research hospital for rehabilitation following proximal femoral fracture surgery
Key exclusion criteria
Exclusion criteria included patients with dairy allergies, those requiring parenteral nutrition, patients with severe dysphagia, patients receiving treatment for hypercalcemia, and those who did not provide informed consent.
Target sample size
60
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
TEL
0258-32-0490
a.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
TEL
0258-32-0490
Homepage URL
a.saito0527@gmail.com
Sponsor or person
Institute
Yoshida hospital
Institute
Department
Personal name
Funding Source
Organization
Yoshida hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagaoka CHUO General
Address
2041, Kawasaki-cho, nagaokashi, niigata
Tel
0258-35-3700
iriyousienka@nagachu.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
No. 567
Org. issuing International ID_1
Nagaoka CHUO General
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
articipants in this study are patients hospitalized at the study institution for rehabilitation after undergoing surgery for a proximal femoral fracture. Participants will be randomly assigned to either a vitamin D-fortified beverage group or a regular milk group upon admission and will continue with their assigned beverage throughout their hospitalization. Blood tests for serum 25(OH)D levels will be conducted at admission and again 2-3 days after admission as the primary outcome measure.
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | 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=R000063547
