HypertensionCSSS-TibetNCT01429246
China Salt Substitute Study in Tibet
A study testing Regular Salt and Salt Substitute in people with Hypertension, run by The George Institute for Global Health, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Regular Salt and Salt Substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Regular Salt, Salt Substitute
- Keywords
- Hypertension, Diet Therapy, Sodium Chloride, Dietary, Tibet, Aged
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular SaltDietary supplement
Estimated Household Individual Consumption of 30 grams per day
Salt SubstituteDietary supplement
Estimated 30 grams per day per household member
| Study group | Role | What they receive |
|---|---|---|
| Normal Salt | Active comparator | 100% Sodium Chloride Receives: Dietary Supplement: Regular Salt |
| Salt Substitute | Experimental | 65% Sodium Chloride, 25% Potassium Chloride, 10% Magnesium Sulphate) Receives: Dietary Supplement: Salt Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months
3 Serial in Right Arm with Seated Patients with at least 1 minute between measurements using Omron 751 Automated Cuff.
Measured: (Baseline compared to 6 months after start of intervention)
Secondary outcomes (2)
Percent of patients having blood pressure under control (<140/90 mmHg)
Measured: Baseline, and post start of intervention at 3 months and 6 months
Change in Baseline Mean Systolic Blood Pressure (mmHg) at 3 months.
3 Serial in Right Arm with Seated Patients with at least 1 minute between measurements using Omron 751 Automated Cuff
Measured: (Baseline compared to 3 months after start of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Beijing Jishuitan Hospital, People's Hospital of Dangxiong County
- Responsible party
- Sponsor
- Investigators
- Yangfeng Wu, PhD, Study director, The George Institute, China (Beijing, CN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429246
- Sponsor's protocol ID
- HHSN268200900027C
- Acronym
- CSSS-Tibet
- Status last verified
- Sep 2011
- First submitted
- 31 Aug 2011
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tian HG, Guo ZY, Hu G, Yu SJ, Sun W, Pietinen P, Nissinen A. Changes in sodium intake and blood pressure in a community-based intervention project in China. J Hum Hypertens. 1995 Dec;9(12):959-68.
PubMed 8746640Hooper L, Bartlett C, Davey SG, Ebrahim S. Advice to reduce dietary salt for prevention of cardiovascular disease. Cochrane Database Syst Rev. 2004;2004(1):CD003656. doi: 10.1002/14651858.CD003656.pub2.
PubMed 14974027He 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.
PubMed 15266549China 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.
PubMed 17885542Zhou 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.
PubMed 19661926He 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.
PubMed 18227813Hu 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.
PubMed 19262499Li 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.
PubMed 18710605Zhao 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.
PubMed 25338053
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Salt Substitute Study in Tibet: Efficacy of Salt Substitute in Reducing Blood Pressure in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT01429246
- Acronym / sponsor ID
- CSSS-Tibet / HHSN268200900027C
- Conditions
- Hypertension
- Keywords
- Hypertension, Diet Therapy, Sodium Chloride, Dietary, Tibet, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Collaborators
- Peking University, Beijing Jishuitan Hospital, People's Hospital of Dangxiong County
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Salt | Active comparator | Dietary Supplement: Regular Salt100% Sodium Chloride |
| Salt Substitute | Experimental | Dietary Supplement: Salt Substitute65% Sodium Chloride, 25% Potassium Chloride, 10% Magnesium Sulphate) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular SaltEstimated Household Individual Consumption of 30 grams per day | Dietary supplement | Normal Salt |
| Salt SubstituteEstimated 30 grams per day per household member | Dietary supplement | Salt Substitute |
Primary outcome
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.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 8746640Tian HG, Guo ZY, Hu G, Yu SJ, Sun W, Pietinen P, Nissinen A. Changes in sodium intake and blood pressure in a community-based intervention project in China. J Hum Hypertens. 1995 Dec;9(12):959-68.
- Background: PubMed 14974027Hooper L, Bartlett C, Davey SG, Ebrahim S. Advice to reduce dietary salt for prevention of cardiovascular disease. Cochrane Database Syst Rev. 2004;2004(1):CD003656. doi: 10.1002/14651858.CD003656.pub2.
- Background: PubMed 15266549He 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.
- Background: PubMed 17885542China 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.
- Background: PubMed 19661926Zhou 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.
- Background: PubMed 18227813He 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.
- Background: PubMed 19262499Hu 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.
- Background: PubMed 18710605Li 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.
- Derived from this study: PubMed 25338053Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangfeng Wu, PhD study director
The George Institute, China (Beijing, CN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Salt and Salt Substitute in people with Hypertension, run by The George Institute for Global Health, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months (time frame: (Baseline compared to 6 months after start of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01429246, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.