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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048060
Receipt No. R000054774
Scientific Title Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial
Date of disclosure of the study information 2022/06/14
Last modified on 2022/06/14

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Basic information
Public title Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial
Acronym vitamin D supplementation on sarcopenia
Scientific Title Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial
Scientific Title:Acronym vitamin D supplementation on sarcopenia
Region
Asia(except Japan)

Condition
Condition sarcopenia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determine the effect of vitamin D3 supplementation on muscle mass and function in sarcopenic elderly Chinese adults with vitamin D insufficiency
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences in serum 25(OH)D, grip strength, gait speed, and relative skeletal mass index changes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1000 IU vitamin D3
Interventions/Control_2 600IU vitamin D3
Interventions/Control_3 placebo
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
60 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria (1)participants over 60 years with insufficient vitamin D [serum 25(OH)D concentrations <75nmol/L].

(2)participants with sarcopenia.
Key exclusion criteria (1) taking vitamin D supplements.

(2) participants with severe depression, cognitive impairment, cardiovascular and cerebrovascular diseases (stroke and myocardial infarction), cancer, impaired hepatic function, impaired renal function, and other serious metabolic diseases.

(3) unable to complete the follow-up.
Target sample size 226

Research contact person
Name of lead principal investigator
1st name Kaijun
Middle name
Last name Niu
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code 300070
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Email nkj0809@gmail.com

Public contact
Name of contact person
1st name Xuena
Middle name
Last name Wang
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code 300070
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Homepage URL
Email wangxuena_1214@163.com

Sponsor
Institute Tianjin Medical University,Nutrition and epidemiology ins
titution
Institute
Department

Funding Source
Organization Tianjin Medical University
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tianjin Medical University
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
Tel +86(0)22-83336613
Email nkj0809@gmail.com

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
2022 Year 06 Month 14 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 226
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
2021 Year 03 Month 05 Day
Date of IRB
2020 Year 11 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 09 Day
Last follow-up date
2021 Year 07 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 14 Day
Last modified on
2022 Year 06 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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