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China Salt Substitute Study in Tibet

NCT01429246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2016-07-29

No results posted yet for this study

Summary

The study was a single-blind randomized controlled trial conducted between February and August 2009 in two townships (Yangbajing and Gongtang) of Dangxiong County, an area at 4300 meters altitude in Tibet. A brief baseline survey and assessment for eligibility was performed before randomization. A total of 282 residents with known hypertension (systolic blood pressure ≥ 140mmHg) were recruited and randomly assigned to intervention or control with stratification by gender and baseline blood pressure. The intervention group received 6-month's supply of salt substitute (68% sodium chloride, 22% potassium chloride and 10% magnesium sulfate heptahydrate) and the control group 6-month's supply of regular salt (100% sodium chloride). After 3-month's intervention, the ones with a blood pressure above 140 mmHg / 90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. The study hypothesis is that salt-substitute will greatly reduce blood pressure in treated patients when compared to controls. Blood pressure levels were measured at baseline and followed up by trained observers using an automated sphygmomanometer and brief survey on level of compliance, amount of salt consumed, and reasons for non-compliance.

Conditions

Interventions

DIETARY_SUPPLEMENT

Regular Salt

Estimated Household Individual Consumption of 30 grams per day

DIETARY_SUPPLEMENT

Salt Substitute

Estimated 30 grams per day per household member

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Beijing Jishuitan Hospital

    collaborator OTHER

  • People's Hospital of Dangxiong County

    collaborator OTHER

  • The George Institute for Global Health, China

    lead OTHER

Principal Investigators

  • Yangfeng Wu, PhD · The George Institute, China (Beijing, CN)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429246 on ClinicalTrials.gov