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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | sarcopenia | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 226 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
nkj0809@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |