UMIN-CTR Clinical Trial

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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