Clinical trial NCT01429246: China Salt Substitute Study in Tibet
Official title: China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Diet Therapy
Sodium Chloride, Dietary
Tibet
Aged
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Peking University
name: Beijing Jishuitan Hospital
name: People's Hospital of Dangxiong County
First posted: 2011-09-07
Enrollment: 282
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months
timeFrame: (Baseline compared to 6 months after start of intervention)
Secondary outcomes:
measure: Percent of patients having blood pressure under control (<140/90 mmHg)
timeFrame: Baseline, and post start of intervention at 3 months and 6 months
measure: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 3 months.
timeFrame: (Baseline compared to 3 months after start of intervention)
Other outcomes:
Locations:
city: Lhasa
country: China
facility: Dangxiong People's Hospital
state: Tibet
Study officials:
affiliation: The George Institute, China (Beijing, CN)
name: Yangfeng Wu, PhD
role: STUDY_DIRECTOR
References:
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citation: He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev. 2004;(3):CD004937. doi: 10.1002/14651858.CD004937.
citation: China Salt Substitute Study Collaborative Group. Salt substitution: a low-cost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens. 2007 Oct;25(10):2011-8. doi: 10.1097/HJH.0b013e3282b9714b.
citation: Zhou X, Liu JX, Shi R, Yang N, Song DL, Pang W, Li YM. Compound ion salt, a novel low-sodium salt substitute: from animal study to community-based population trial. Am J Hypertens. 2009 Sep;22(9):934-42. doi: 10.1038/ajh.2009.135. Epub 2009 Aug 6.
citation: He FJ, MacGregor GA. Can a low-sodium, high-potassium salt substitute reduce blood pressure in rural Chinese people? Nat Clin Pract Cardiovasc Med. 2008 Apr;5(4):186-7. doi: 10.1038/ncpcardio1122. Epub 2008 Jan 29. No abstract available.
citation: Hu J, Jiang X, Li N, Yu X, Perkovic V, Chen B, Zhao L, Neal B, Wu Y. Effects of salt substitute on pulse wave analysis among individuals at high cardiovascular risk in rural China: a randomized controlled trial. Hypertens Res. 2009 Apr;32(4):282-8. doi: 10.1038/hr.2009.7. Epub 2009 Feb 27.
citation: Li N, Prescott J, Wu Y, Barzi F, Yu X, Zhao L, Neal B; China Salt Substitute Study Collaborative Group. The effects of a reduced-sodium, high-potassium salt substitute on food taste and acceptability in rural northern China. Br J Nutr. 2009 Apr;101(7):1088-93. doi: 10.1017/S0007114508042360. Epub 2008 Aug 19.
citation: Zhao X, Yin X, Li X, Yan LL, Lam CT, Li S, He F, Xie W, Sang B, Luobu G, Ke L, Wu Y. Using a low-sodium, high-potassium salt substitute to reduce blood pressure among Tibetans with high blood pressure: a patient-blinded randomized controlled trial. PLoS One. 2014 Oct 22;9(10):e110131. doi: 10.1371/journal.pone.0110131. eCollection 2014.