Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

April 9, 2024 updated by: Limeng Chen

Chinese Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Prevalence Survey

This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The prevalence of Chronic Kidney Disease (CKD) in Chinese population is over 10% and increasing rapidly. Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a constellation of conditions secondary to CKD, including 1) metabolic disorders of calcium, phosphorus and Parathyroid Hormone (PTH), 2) bone diseases and 3) calcifications in blood vessels and soft tissues. CKD-MBD could increase the risks of cardiovascular diseases and bone fracture and overall mortality. However, the data of prevalence of CKD-MBD in Chinese population with different CKD stages is lacking. This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population. A questionnaire was designed to collect the information of demographic data, medical history, laboratory test results and medications from the patients. Multistage stratified cluster sampling method will be used. Based on the sample size estimation, a total of 14-28 tertiary hospitals and 42-56 level II hospitals distributed in seven different geographic regions across China will be included. At least 9863 subjects will be enrolled. The primary outcome is the prevalence of CKD-MBD, including the prevalence of hypocalcemia, hyperphosphatemia and secondary hyperparathyroidism.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaohong Fan, MD
  • Phone Number: +86-13811559757
  • Email: fxhcmu@163.com

Study Contact Backup

  • Name: Peng Xia, MD
  • Phone Number: +86-13811684903
  • Email: 7-xp@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Xiaohong Fan, MD
          • Phone Number: +86-13811559757
          • Email: fxhcmu@163.com
        • Contact:
          • Peng Xia, MD
          • Phone Number: +86-1381168403
          • Email: 7-xp@163.com
        • Sub-Investigator:
          • Xiaohong Fan, MD
        • Principal Investigator:
          • Limeng Chen, MD, PhD
        • Sub-Investigator:
          • Peng Xia, MD
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yilun Zhou, PhD
        • Sub-Investigator:
          • Yin Zhang, PhD
        • Sub-Investigator:
          • Yong Gong, MD
        • Sub-Investigator:
          • Jing Liu, MD
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guojuan Zhang, MD
        • Sub-Investigator:
          • Kangkang Song, MD
        • Sub-Investigator:
          • Shumin Bao, MD
        • Sub-Investigator:
          • Qiaojing Liang, MM
        • Sub-Investigator:
          • Binghan Li, MD
        • Sub-Investigator:
          • Ning Ding, MM
        • Sub-Investigator:
          • Xiuji Li, MD
      • Beijing, Beijing, China, 101149
        • Recruiting
        • Beijing Lu-He Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhongxin Li, MD
        • Sub-Investigator:
          • Chunxia Shi, MM
        • Sub-Investigator:
          • Xiaojing Liu, MM
        • Sub-Investigator:
          • Qianying Cao, MM
      • Beijing, Beijing, China, 102400
        • Recruiting
        • The First Hospital of Fangshan District, Beijing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xufang Yu, MM
        • Sub-Investigator:
          • Xin Jiang, BM
        • Sub-Investigator:
          • Mingzhu Ji, BM
        • Sub-Investigator:
          • Huibo Yang, BM
        • Sub-Investigator:
          • Lin He, BM
        • Sub-Investigator:
          • Shanshan Wang, BM
        • Sub-Investigator:
          • Yangyang Chen, BM
      • Beijing, Beijing, China, 102600
        • Recruiting
        • Beijing Daxing District People'S Hospital
        • Contact:
        • Principal Investigator:
          • Peiyi Zhou, M.D.
        • Sub-Investigator:
          • Dongqi Song, M.D.
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital, Chongqing Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hua Gan, MD, PhD
        • Sub-Investigator:
          • Xiaogang Du, MD, PhD
        • Sub-Investigator:
          • Enhao Yang, MD, PhD
        • Sub-Investigator:
          • Wen Wen, MSc
      • Chongqing, Chongqing, China, 400700
        • Recruiting
        • The Ninth People'S Hospital of Chongqing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoling Gao, MM
        • Sub-Investigator:
          • Jia Yang, MD
        • Sub-Investigator:
          • Qinglin Jia, MM
        • Sub-Investigator:
          • Wenjing Zhu, MM
        • Sub-Investigator:
          • Yang Luo, MM
        • Sub-Investigator:
          • Jing Mei, MM
      • Chongqing, Chongqing, China, 400021
        • Recruiting
        • Chongqing Hospital of Traditional Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ling Zhang, BM
        • Sub-Investigator:
          • Ying Li, MD
        • Sub-Investigator:
          • Huihui Li, MD
      • Chongqing, Chongqing, China, 401120
        • Recruiting
        • The Third Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jurong Yang, MD
        • Sub-Investigator:
          • Shuyu Gong, MM
        • Sub-Investigator:
          • Bengang Huo, MM
        • Sub-Investigator:
          • Lirong Lin, MM
        • Sub-Investigator:
          • Lei Zhao, MM
        • Sub-Investigator:
          • En Tian, MM
      • Chongqing, Chongqing, China, 405200
        • Recruiting
        • People's Hospital of Liangping District, Chongqing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongwen Zhou, MM
      • Chongqing, Chongqing, China, 408200
        • Recruiting
        • The People's Hospital of Fengdu County
        • Contact:
        • Contact:
          • Yang Liu
          • Phone Number: +86-18372552345
        • Principal Investigator:
          • Chenghui Tao, BM
        • Sub-Investigator:
          • Yang Liu, MM
        • Sub-Investigator:
          • Qiaodan Liu, BM
      • Chongqing, Chongqing, China, 408400
        • Recruiting
        • The People's Hospital of Nanchuan District, Chongqing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jie Huo, BM
        • Sub-Investigator:
          • You Zhang, BM
        • Sub-Investigator:
          • Hongmei Xia, BM
        • Sub-Investigator:
          • Yalin Zeng, MM
        • Sub-Investigator:
          • Liangjun Zhou, BM
        • Sub-Investigator:
          • Xia Li, MM
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fuyuan Hong, MD
        • Sub-Investigator:
          • Jinbin Wu, MM
        • Sub-Investigator:
          • Li Zhang, MM
        • Sub-Investigator:
          • Yiping Ruan, MD
        • Sub-Investigator:
          • Meizhu Gao, MM
        • Sub-Investigator:
          • Fuxin Dong, MM
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tianjun Guan, MD
        • Sub-Investigator:
          • Xiaodan Guo, MM
      • Zhangzhou, Fujian, China, 363099
        • Recruiting
        • Zhangzhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Rui Wu, BM
        • Sub-Investigator:
          • Liling Cai, BM
        • Sub-Investigator:
          • Chaoqun Guo, MM
    • Guangdong
      • Foshan, Guangdong, China, 528300
        • Recruiting
        • Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xianrui Dou, MD
        • Sub-Investigator:
          • Jianyi Pan, MM
        • Sub-Investigator:
          • Wei Zhang, BM
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Panyu Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Minyan Xie, BM
        • Sub-Investigator:
          • Jianer Zhou, MM
        • Sub-Investigator:
          • Xiaojun Fu, MM
        • Sub-Investigator:
          • Jian Guo, MM
        • Sub-Investigator:
          • Yanhuan He, MM
        • Sub-Investigator:
          • Dongsheng Zhang, BM
        • Sub-Investigator:
          • Fang Wang, MM
      • Guangzhou, Guangdong, China, 520120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qiongqiong Yang, MD
        • Sub-Investigator:
          • Rong Huang, MD
        • Sub-Investigator:
          • Wenlu Li, BM
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • The Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhihua Zheng, MD
        • Sub-Investigator:
          • Jinhong Li, MD
        • Sub-Investigator:
          • Juan Yang, MD
      • Shenzhen, Guangdong, China, 518109
        • Recruiting
        • The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mingliang Hu, MD
        • Sub-Investigator:
          • Liting Xu, MM
        • Sub-Investigator:
          • Ting Yan, MM
        • Sub-Investigator:
          • Li Wang, BM
        • Sub-Investigator:
          • Sha Li, MM
        • Sub-Investigator:
          • Yihao Mo, MM
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhenhua Yang, MD
        • Sub-Investigator:
          • Chengyu Wang, MM
        • Sub-Investigator:
          • Shihua Li, MM
        • Sub-Investigator:
          • Liyuan Bei, MM
        • Sub-Investigator:
          • Yue Wu, MM
        • Sub-Investigator:
          • Cuicui Deng, BM
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Hui Xu, MD
        • Sub-Investigator:
          • Cuifang Li, MM
      • Yiyang, Hunan, China, 413000
        • Recruiting
        • Third People's Hospital of Yiyang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoyan Hu, BM
        • Sub-Investigator:
          • Shaode Zhang, BM
        • Sub-Investigator:
          • Hui Li, BM
        • Sub-Investigator:
          • Sha Li, BM
        • Sub-Investigator:
          • Biao Chen, BM
        • Sub-Investigator:
          • Yuehong Peng, BM
        • Sub-Investigator:
          • Yuehua Chen, BM
    • Liaoning
      • Anshan, Liaoning, China, 114000
        • Recruiting
        • Anshan Central Hospital, Lishan District
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cong Ma, BM
        • Sub-Investigator:
          • Ruiting Lv, BM
        • Sub-Investigator:
          • Yi Sui, MM
        • Sub-Investigator:
          • Xiaoying Zhao, BM
        • Sub-Investigator:
          • Zhenggang Han, BM
        • Sub-Investigator:
          • Lisong Wang, BM
      • Benxi, Liaoning, China, 117000
        • Recruiting
        • Benxi Steel General Hospital of Liaoning Health Industry Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huiming Wang, MM
      • Dalian, Liaoning, China, 116001
        • Recruiting
        • Dalian University Affiliated Xinhua Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lin Wang, MM
        • Sub-Investigator:
          • Qiangqiang Liu, MM
        • Sub-Investigator:
          • Minghui Xin, MM
        • Sub-Investigator:
          • Yu Wang, MM
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Li Yao, MD, PhD
        • Sub-Investigator:
          • Xinwang Zhu, MD, PhD
    • Ningxia
      • Guyuan, Ningxia, China, 756000
        • Recruiting
        • Traditional Chinese Hospital of Guyuan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shiqiang Shi, BM
        • Sub-Investigator:
          • Lin Hu, BM
        • Sub-Investigator:
          • Wei Ma, BM
      • Guyuan, Ningxia, China, 756300
        • Recruiting
        • People's Hospital of Longde County
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kangzhong Zhang, BM
        • Sub-Investigator:
          • Lang Luo, BM
      • Shizuishan, Ningxia, China, 753000
        • Recruiting
        • The Fifth People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fengxia Wang, MM
        • Sub-Investigator:
          • Yupu Dou, MM
        • Sub-Investigator:
          • Rui Zhang, BM
        • Sub-Investigator:
          • Xian Zhang, BM
      • Wuzhong, Ningxia, China, 751100
        • Recruiting
        • People's Hospital of Wuzhong
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongyan Yan, MM
        • Sub-Investigator:
          • Xiaoxia Luo, MM
      • Wuzhong, Ningxia, China, 751300
        • Recruiting
        • People's Hospital of Tongxin County
        • Contact:
        • Contact:
        • Principal Investigator:
          • Weiquan Zhang, BM
        • Sub-Investigator:
          • Lingyan Ma, BM
      • Wuzhong, Ningxia, China, 751500
        • Recruiting
        • People's Hospital of Yanchi County
        • Contact:
          • Zhiwen Zhang, BM
          • Phone Number: +86-13909534706
          • Email: ywkzzw@163.com
        • Principal Investigator:
          • Zhiwen Zhang, BM
        • Sub-Investigator:
          • Xianwen Zhang, BM
        • Sub-Investigator:
          • Pan Zhang, BM
      • Wuzhong, Ningxia, China, 756000
        • Recruiting
        • People's Hospital of Yuanzhou District
        • Contact:
        • Contact:
          • Bo Lu, BM
          • Phone Number: +86-15009648668
        • Principal Investigator:
          • Lili Ao, BM
        • Sub-Investigator:
          • Ningchun Liu, BM
      • Yinchuan, Ningxia, China, 750001
        • Recruiting
        • The First People's Hospital of Yinchuan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peng Zhang, BM
        • Sub-Investigator:
          • Liyuan Ma, MM
        • Sub-Investigator:
          • Bo Zhao, MM
      • Yinchuan, Ningxia, China, 750001
        • Recruiting
        • Ningxia Chinese Medicine Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiaxiu Li, MM
        • Sub-Investigator:
          • Jiangwei Zhang, MM
        • Sub-Investigator:
          • Qingyang Xu, MM
      • Yinchuan, Ningxia, China, 750001
        • Recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yali Zheng, MD
        • Sub-Investigator:
          • Li Cao, MM
        • Sub-Investigator:
          • Danna Ma, MM
        • Sub-Investigator:
          • Guoqing Zhang, MM
        • Sub-Investigator:
          • Jing E, MM
        • Sub-Investigator:
          • Xiumei Zhang, MM
        • Sub-Investigator:
          • Bo Li, MM
        • Sub-Investigator:
          • Kaixiang Li, MM
        • Sub-Investigator:
          • Jinping Yao, BM
        • Sub-Investigator:
          • Lurong Zou, BM
        • Sub-Investigator:
          • Feifei Luo, BM
        • Sub-Investigator:
          • Lirui Jia, BM
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Not yet recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chen Lu, MD
        • Sub-Investigator:
          • Shiru Xu, MM
        • Sub-Investigator:
          • Adila Abulizi, MM
        • Sub-Investigator:
          • Hui Luo, MM
        • Sub-Investigator:
          • Jing Zhuang, MM
        • Sub-Investigator:
          • Xueqin Zhang, MM
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Lijun Mou, MD, PhD
        • Sub-Investigator:
          • Ying Hu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study plans to include hospitalized CKD patients who are not on dialysis and dialysis patients followed regularly in HD centers or PD centers.

Description

Inclusion Criteria:

  • Kidney damage for ≥ 3 months, and one of the following criteria:

    1. Glomerular filtration rate (GFR) <60 mL/min/1.73m2 for 3 months or more, irrespective of cause.
    2. proteinuria (>30 mg of urinary albumin excretion per gram of urinary creatinine, > 50 mg of urinary protein excretion per gram of urinary creatinine, >1+ for proteinuria in dipstick, > 0.3g of 24 hour urine protein)
    3. structural renal abnormalities
  • hospitalized patients not on dialysis or dialysis patients followed regularly in Hemodialysis centers or Peritoneal Dialysis centers

Exclusion Criteria:

  • no available test results within 3 months prior to this study
  • no available information of medication or past medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prevalence of hyperphosphatemia
Time Frame: At the end of the enrollment.
The prevalence of hyperphosphatemia (serum phosphate > 1.45mmol/L) in the whole study population and in participants with different CKD stages.
At the end of the enrollment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prevalence of hypocalcemia
Time Frame: At the end of the enrollment.
The prevalence of hypocalcemia (serum calcium < 2.13mmol/L) in the whole study population and in participants with different CKD stages.
At the end of the enrollment.
The prevalence of secondary hyperparathyroidism
Time Frame: At the end of the enrollment.
The prevalence of secondary hyperparathyroidism (iPTH > 300pg/ml) in the whole study population and in participants with different CKD stages.
At the end of the enrollment.
The prevalence of hypercalcemia
Time Frame: At the end of the enrollment.
The prevalence of hypercalcemia (serum calcium > 2.70mmol/L) in the whole study population and in participants with different CKD stages.
At the end of the enrollment.
The prevalence of bone fracture
Time Frame: At the end of the enrollment.
The prevalence of bone fracture in the whole study population and in participants with different CKD stages.
At the end of the enrollment.
The prevalence of vascular calcification
Time Frame: At the end of the enrollment.
The prevalence of vascular calcification identified by CT scan or ultrasound in the whole study population and in participants with different CKD stages.
At the end of the enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Limeng Chen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Limeng Chen, MD, PhD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRISS-MBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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