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Tibet Salt Reduction Study

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ClinicalTrials.gov Identifier: NCT02021435
Recruitment Status : Unknown
Verified January 2014 by Xingshan Zhao, Beijing Jishuitan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 27, 2013
Last Update Posted : January 10, 2014
Sponsor:
Collaborators:
The George Institute for Global Health at PUHSC
The George Institute for Global Health, Australia
Science and Technology Department of Ningxia
People's Hospital of Tibet
People's Hospital of Maizhokunggar
Tibet University
Peking University
People's Hospital of Damxung County, Tibet
Information provided by (Responsible Party):
Xingshan Zhao, Beijing Jishuitan Hospital

Brief Summary:
  1. Research background

    - High blood pressure is one of the most important risk factors to cardiovascular diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower mortality effectively. Much research has proven that adjusting for Na and K intake level can reduce blood pressure. According to the China Salt Substitute Study, the systolic blood pressure of intervention group which used salt substitute is 5.4 mmHg lower than that of control group. Life expectancy in Tibet is 67 years old. It is estimated that the use of salt substitute among population in Tibet can reduce total mortality in Tibet by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found that salt substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China (unpublished results). However, the study focused on hypertensive patients, the effectiveness of hypertension control by providing free salt substitute to the entire population remains unknown, and a large-scale trial is needed.

  2. Objectives

    - Primary objective is to observe the effect of providing salt substitute on population blood pressure in Tibet. Secondary objective is to observe the effect of such intervention on population mortality, cardiovascular mortality and life expectancy. In addition, the data collected from high-risk population (sub-group) in the study will be used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and random blood glucose of people over 60 in Tibet will be collected.

  3. Method

    • The study is a open, cluster-randomized, controlled trial.
    • 30 villages with 15 to 35 households each and a distance of at least five kilometers in between will be selected from Damxung county and Maizhokunggar county. The two counties have an average altitude of over 4000 meters in Tibet Autonomous Region.
    • All selected villages will be randomly assigned to intervention group or control group on a 1:1 ratio.
    • All household in the selected villages will be recruited if they meet the eligibility criteria. Approximately 4,500 participants will be enrolled
    • Intervention group receives free salt substitute. Control group will continue to buy their own normal salt. Both group will receive the same health education on salt reduction.
  4. Outcome - Primary outcome is blood pressure. Secondary outcomes include total mortality, cardiovascular disease mortality, life expectancy, serum cholesterol level of people over 60, and random blood glucose level of people over 60.

Condition or disease Intervention/treatment Phase
Blood Pressure Cardiovascular Diseases Death Dietary Supplement: salt substitute Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Salt Substitute to Reduce Population Blood Pressure in Tibet: Tibet Salt Reduction Study
Study Start Date : April 2014
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Salt Substitute
salt substitute
Dietary Supplement: salt substitute
Free salt substitute provided

No Intervention: Control
Participants continue to buy salt at their own expense



Primary Outcome Measures :
  1. Difference in change from baseline in blood pressure between intervention and control [ Time Frame: Baseline, 6,12, 24 months ]

Secondary Outcome Measures :
  1. Difference in total mortality between intervention and control [ Time Frame: 6, 12, 24 months ]
  2. Difference in cardiovascular disease mortality between intervention and control [ Time Frame: 6,12, 24 months ]
  3. Difference in life expectancy between intervention and control group [ Time Frame: 6, 12, 24 months ]
  4. The distribution of blood glucose level in population over 60 years old [ Time Frame: baseline ]
  5. Distribution of serum cholesterol level in population over 60 years old [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All family households in the selected satellite village will be invited to participate in the study

Family households will be excluded from participating if they meet one or more of the following exclusion criteria:

  • Any member in the family is using a potassium-sparing diuretic
  • Any member in the family is using a potassium supplement
  • Any member in the family has serious renal impairment
  • Any member in the family over 18 could not sign informed consent
  • Life expectancy of any member in the family is shorter than 6 months in doctor's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021435


Contacts
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Contact: Xingshan Zhao, M.D. 86-13701326978 xingshanzh@gmail.com

Locations
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China, Tibet
Damxung, Tibet, China, 851500
Maizhokunggar, Tibet, China, 850200
Sponsors and Collaborators
Beijing Jishuitan Hospital
The George Institute for Global Health at PUHSC
The George Institute for Global Health, Australia
Science and Technology Department of Ningxia
People's Hospital of Tibet
People's Hospital of Maizhokunggar
Tibet University
Peking University
People's Hospital of Damxung County, Tibet
Investigators
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Principal Investigator: Xingshan Zhao, M.D. Beijing Jishuitan Hospital
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Responsible Party: Xingshan Zhao, Vice-president; Director, Department of Cardiology, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT02021435    
Other Study ID Numbers: 2013BAI05B04
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Cardiovascular Diseases