UMIN-CTR 臨床試験登録情報の閲覧

基本情報/Basic information
一般向け試験名/Public title	Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial	Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial
一般向け試験名略称/Acronym	vitamin D supplementation on sarcopenia	vitamin D supplementation on sarcopenia
科学的試験名/Scientific Title	Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial	Effect of vitamin D supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a randomized controlled trial
科学的試験名略称/Scientific Title:Acronym	vitamin D supplementation on sarcopenia	vitamin D supplementation on sarcopenia
試験実施地域/Region	アジア（日本以外）/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition	sarcopenia	sarcopenia
疾患区分1/Classification by specialty	老年内科学/Geriatrics
疾患区分2/Classification by malignancy	悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information	いいえ/NO

目的/Objectives
目的1/Narrative objectives1	to determine the effect of vitamin D3 supplementation on muscle mass and function in sarcopenic elderly Chinese adults with vitamin D insufficiency	to determine the effect of vitamin D3 supplementation on muscle mass and function in sarcopenic elderly Chinese adults with vitamin D insufficiency
目的2/Basic objectives2	安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes	The differences in serum 25(OH)D, grip strength, gait speed, and relative skeletal mass index changes.	The differences in serum 25(OH)D, grip strength, gait speed, and relative skeletal mass index changes.
副次アウトカム評価項目/Key secondary outcomes

基本事項/Base
試験の種類/Study type	介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design	並行群間比較/Parallel
ランダム化/Randomization	ランダム化/Randomized
ランダム化の単位/Randomization unit	個別/Individual
ブラインド化/Blinding	二重盲検/Double blind -all involved are blinded
コントロール/Control	プラセボ・シャム対照/Placebo
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms	3
介入の目的/Purpose of intervention	治療・ケア/Treatment
介入の種類/Type of intervention	食品/Food
介入1/Interventions/Control_1	1000 IU vitamin D3	1000 IU vitamin D3
介入2/Interventions/Control_2	600IU vitamin D3	600IU vitamin D3
介入3/Interventions/Control_3	placebo	placebo
介入4/Interventions/Control_4
介入5/Interventions/Control_5
介入6/Interventions/Control_6
介入7/Interventions/Control_7
介入8/Interventions/Control_8
介入9/Interventions/Control_9
介入10/Interventions/Control_10

適格性/Eligibility
年齢（下限）/Age-lower limit	60 歳/years-old 以上/<=
年齢（上限）/Age-upper limit	100 歳/years-old 以下/>=
性別/Gender	男女両方/Male and Female
選択基準/Key inclusion criteria	(1)participants over 60 years with insufficient vitamin D [serum 25(OH)D concentrations <75nmol/L]. (2)participants with sarcopenia.	(1)participants over 60 years with insufficient vitamin D [serum 25(OH)D concentrations <75nmol/L]. (2)participants with sarcopenia.
除外基準/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.	(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.
目標参加者数/Target sample size	226

責任研究者/Research contact person
責任研究者/Name of lead principal investigator	名 Kaijun ミドルネーム 姓 Niu	名 Kaijun ミドルネーム 姓 Niu
所属組織/Organization	Tianjin Medical University	Tianjin Medical University
所属部署/Division name	Nutrition and epidemiology institution	Nutrition and epidemiology institution
郵便番号/Zip code	300070
住所/Address	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
電話/TEL	+86(0)22-83336613
Email/Email	nkj0809@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person	名 Xuena ミドルネーム 姓 Wang	名 Xuena ミドルネーム 姓 Wang
組織名/Organization	Tianjin Medical University	Tianjin Medical University
部署名/Division name	Nutrition and epidemiology institution	Nutrition and epidemiology institution
郵便番号/Zip code	300070
住所/Address	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
電話/TEL	+86(0)22-83336613
試験のホームページURL/Homepage URL
Email/Email	wangxuena_1214@163.com

実施責任組織/Sponsor
機関名/Institute	その他	Tianjin Medical University,Nutrition and epidemiology ins titution
機関名/Institute （機関選択不可の場合）	Tianjin Medical University,Nutrition and epidemiology ins titution
部署名/Department

研究費提供組織/Funding Source
機関名/Organization	その他	Tianjin Medical University
機関名/Organization （機関選択不可の場合）	Tianjin Medical University
組織名/Division
組織の区分/Category of Funding Organization	海外/Outside Japan
研究費拠出国/Nationality of Funding Organization

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
その他の研究費提供組織/Name of secondary funder(s)

IRB等連絡先（公開）/IRB Contact (For public release)
組織名/Organization	Tianjin Medical University	Tianjin Medical University
住所/Address	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.	22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
電話/Tel	+86(0)22-83336613
Email/Email	nkj0809@gmail.com

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs	いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1
試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2
治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日（本登録希望日）/Date of disclosure of the study information	2022 年 06 月 14 日

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results	未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled	226
主な結果/Results
主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason
最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics
参加者の流れ/Participant flow
有害事象/Adverse events
評価項目/Outcome measures
個別症例データ共有計画/Plan to share IPD
個別症例データ共有計画の詳細/IPD sharing Plan description

試験進捗状況/Progress
試験進捗状況/Recruitment status	参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation	2021 年 03 月 05 日
倫理委員会による承認日/Date of IRB	2020 年 11 月 16 日
登録・組入れ開始（予定）日/Anticipated trial start date	2021 年 04 月 09 日
フォロー終了(予定)日/Last follow-up date	2021 年 07 月 09 日
入力終了(予定)日/Date of closure to data entry
データ固定（予定）日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information

管理情報/Management information
登録日時/Registered date	2022 年 06 月 14 日
最終更新日/Last modified on	2022 年 06 月 14 日

閲覧ページへのリンク/Link to view the page
URL(日本語)	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000054774
URL(英語)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054774