NCT02021435

Brief Summary

  • 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.
  • 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

December 20, 2013

Last Update Submit

January 8, 2014

Conditions

Blood PressureCardiovascular DiseasesDeath

Outcome Measures

Primary Outcomes (1)

  • Difference in change from baseline in blood pressure between intervention and control

    Baseline, 6,12, 24 months

Secondary Outcomes (5)

  • Difference in total mortality between intervention and control

    6, 12, 24 months

  • Difference in cardiovascular disease mortality between intervention and control

    6,12, 24 months

  • Difference in life expectancy between intervention and control group

    6, 12, 24 months

  • The distribution of blood glucose level in population over 60 years old

    baseline

  • Distribution of serum cholesterol level in population over 60 years old

    baseline

Study Arms (2)

Salt Substitute

EXPERIMENTAL

salt substitute

Dietary Supplement: salt substitute

Control

NO INTERVENTION

Participants continue to buy salt at their own expense

Interventions

salt substituteDIETARY_SUPPLEMENT

Free salt substitute provided

Salt Substitute

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Damxung, Tibet, 851500, China

Location

Unknown Facility

Maizhokunggar, Tibet, 850200, China

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDeath

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xingshan Zhao, M.D.

    Beijing Jishuitan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshan Zhao, M.D.

CONTACT

86-13701326978xingshanzh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-president; Director, Department of Cardiology

Study Record Dates

First Submitted

December 20, 2013

First Posted

December 27, 2013

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

CN(2)