China Salt Substitute Study in Tibet (CSSS-Tibet)
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|ClinicalTrials.gov Identifier: NCT01429246|
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment|
|Hypertension||Dietary Supplement: Regular Salt Dietary Supplement: Salt Substitute|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults|
|Study Start Date :||February 2009|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
Active Comparator: Normal Salt
100% Sodium Chloride
Dietary Supplement: Regular Salt
Estimated Household Individual Consumption of 30 grams per day
Experimental: Salt Substitute
65% Sodium Chloride, 25% Potassium Chloride, 10% Magnesium Sulphate)
Dietary Supplement: Salt Substitute
Estimated 30 grams per day per household member
- Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months [ Time Frame: (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.
- Percent of patients having blood pressure under control (<140/90 mmHg) [ Time Frame: Baseline, and post start of intervention at 3 months and 6 months ]
- Change in Baseline Mean Systolic Blood Pressure (mmHg) at 3 months. [ Time Frame: (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
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): NCT01429246
|Dangxiong People's Hospital|
|Lhasa, Tibet, China, 850000|
|Study Director:||Yangfeng Wu, PhD||The George Institute, China (Beijing, CN)|