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China Salt Substitute Study in Tibet

China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01429246
Acronym
CSSS-Tibet
Enrollment
282
Registered
2011-09-07
Start date
2009-02-28
Completion date
2009-08-31
Last updated
2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Diet Therapy, Sodium Chloride, Dietary, Tibet, Aged

Brief 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.

Detailed description

Hypertension is one of the most important risk factors that induce cardiovascular and cerebrovascular disease. Reducing the blood pressure levels of population can not only control the incidence of cardiovascular and cerebrovascular disease effectively, but also reduce the mortality. Anti-hypertension drug therapy has been proven to be an effective method to reduce blood pressure. Dietary sodium restriction and potassium supplementation is the core of dietary approaches to stop hypertension. Tibet is located on the Tibetan Plateau with an average altitude about 4000 meters above sea level. Tibetan diet is rich in meat but poor in vegetables and fruits. Salt intake is quite high due to habitual drinking of salty butter tea. Former national surveys showed a high prevalence of hypertension in Tibet. The investigators conducted this randomized controlled intervention study to test whether the investigators can offer a cost effective way to lower blood pressure and control hypertension in a sample of subjects from Yangbajing and Gongtang in Dangxiong County, Lhasa, Tibet. A randomized controlled trial was conducted in Yangbajing Township and Gongtang Village in the Dangxiong county , Tibet. A total of 282 hypertensive patients were chosen as study subjects. The regular salt or salt substitution were randomly allocated to the two groups. The whole intervention last for 6 months, with Phase 1 for three months and a following Phase 2 for another three months. For Phase 1, the study subjects were allocated the regular salt or the salt substitute after a randomization. For Phase 2, the study subjects continued the intervention of regular salt or salt substitute while the ones with a blood pressure above 140mmHg/90 mmHg will be given low-dose diuretic for further anti-hypertensive therapy. During the whole intervention period, the study subjects were not informed of what kind of salt they were taking. Blood pressure was the major outcome and would be measured at baseline, 3 months and 6 months.

Interventions

DIETARY_SUPPLEMENTRegular Salt

Estimated Household Individual Consumption of 30 grams per day

DIETARY_SUPPLEMENTSalt Substitute

Estimated 30 grams per day per household member

Sponsors

Peking University
CollaboratorOTHER
Beijing Jishuitan Hospital
CollaboratorOTHER
People's Hospital of Dangxiong County
CollaboratorOTHER
The George Institute for Global Health, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 40 years or older * Resident of Yangbajing Township and Gongtang Village in Tibetan Autonomous Region, People's Republic of China * Mean Systolic Hypertension (≥ 140 mmHg)

Exclusion criteria

* Currently taking any potassium supplements (or lives in household where someone does) * Previously diagnosed kidney disease or gout (or lives in a household where someone does) and physician considered he/she cannot take salt substitute. * Any person who intended to use salt outside the assigned treatment salt provide in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months(Baseline compared to 6 months after start of intervention)3 Serial in Right Arm with Seated Patients with at least 1 minute between measurements using Omron 751 Automated Cuff.

Secondary

MeasureTime frameDescription
Percent of patients having blood pressure under control (<140/90 mmHg)Baseline, and post start of intervention at 3 months and 6 months
Change in Baseline Mean Systolic Blood Pressure (mmHg) at 3 months.(Baseline compared to 3 months after start of intervention)3 Serial in Right Arm with Seated Patients with at least 1 minute between measurements using Omron 751 Automated Cuff

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026