HypertensionSMASHNCT03296332
Shandong and Ministry of Health Action on Salt and Hypertension Project
An observational study of Hypertension, run by Centers for Disease Control and Prevention, China at 1 site in China.
Trial summary
This final evaluation intends to evaluate SMASH implementation outcomes and intervention effects through quantitative and qualitative assessment, and provide evidence for the national government to develop salt-reduction and blood-pressure lowering strategies in large scales. Read more about this study
- Who is it for?
- Ages 6 to 69 years
- Conditions the study is for
- Hypertension
- How many people
- 17,160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2017
- Phase
- Observational
- 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 6 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Respondents are permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages), but those with severe physical or mental diseases can't participate. The survey is conducted at the same time as the SMASH baseline survey in June-July 2016. Basic demographic information, disease information, hypertension risk elements, knowledge of salt and hypertension, belief and behavior of respondents will be objectively collected and recorded through questionnaires by trained investigators from respondents. The respondents aged 18-69 are sampled from villages and urban neighborhood communities, while those aged 6-17 are sampled from schools.
Who may be able to join
- Permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages).
Who cannot join
- Residents with severe physical or mental diseases.
- Urine can't be collected due to aconuresis;
- The candidate has difficulty to collect urine and can't find an assistant;
- Patients with acute/chronic urinary tract infection, vaginal infection and perianal infection;
- Patients with acute hemorrhagic diseases in urinary tract, vagina and digestive tract;
- Women in pregnancy, lactation and menstrual periods (those whose menstruation finishes for two days are eligible);
- Patients with severe vomiting and diarrhea symptoms.
Trial locations and contacts
1 site in 1 country.
China1 site
The National Center for Chronic and Noncommunicable Disease Control and Prevention
Beijing, Beijing Municipality, 100050
About this study
Official title: Shandong and Ministry of Health Action on Salt and Hypertension Project (SMASH)
This final evaluation intends to evaluate SMASH implementation outcomes and intervention effects through quantitative and qualitative assessment, and provide evidence for the national government to develop salt-reduction and blood-pressure lowering strategies in large scales.
Read the detailed description
Every year, about 1.65 million people die of excessive salt intake in the world as excessive sodium will raise blood pressure, which further increase prevalence risks of cardiovascular and kidney diseases. Therefore, reducing salt intake has been recognized as one of the most cost-effective measures for health improvement. Adopting critical salt-reduction measures can substantially reduce prevalence risks of cardiovascular and other chronic diseases. In this sense, exploring salt-reduction strategies that are widely effective among populations is critical for prevention and management of cardiovascular diseases.
The daily salt intake currently recommended by WHO is 5g (6g is recommended by Chinese government). It is estimated that 2.50 million people will not die each year if the global salt consumption is lowered to the recommended level. WHO member countries have reached an agreement to reduce 30% of the salt intake of people across the world by 2025. However, there are not enough study evidence and practical foundation for achieving the salt-reduction goal among all human beings.
Shandong is a large Chinese province with 96.85 million permanent population in its 138 counties (districts) and 62,719 communities (villages or municipal neighborhood communities). Shandong has high prevalences of cardiovascular diseases with an adult hypertensive prevalence above the national average. According to the national nutrition survey in 2002, Shandong consumed 12.6g salt per capita for daily cooking, much higher than the recommended amount (6g) in Chinese dietary guidelines. Shandong and the Ministry of Health signed a five-year cooperative agreement in 2011, Shandong-MOH Action on Salt and Hypertension ("SMASH"). The program has adopted multi-angle and multi-level intervention strategies to reduce salt intake by people for the purpose of preventing hypertension and other diseases related to salt.
SMASH baseline survey in 2011 studied 15,350 people aged 18-69 by regions and towns with multi-stage cluster random sampling to investigate their blood pressures and conditions. The survey showed that hypertensive prevalence, awareness, treatment and control rates were 23.4%, 34.5%, 27.5%, 14.9% respectively. In the baseline survey, 24-hour urine of 2,112 people was collected, and a salt intake of 13.8g per person per day was obtained in accordance with the urinary sodium data.
Since the commencement of the program, Shandong provincial government has cooperated with relevant departments to establish a work mechanism that is led by MOH, implemented by professional institutes and extensively engaged by the whole society. The program team has developed food standards and regulations and promoted salt-reduction actions in catering entities, supermarkets and food processing enterprises for a favorable environment of the program. The program team has prepared various publicity materials, and trained key groups (catering workers, food manufacturers, housewives and elementary school students). Salt consumption monitoring points and cardiovascular prevalence monitoring system have been established.
SMASH will conclude in May 2016. In order to assess the intervention course, implementation outcomes and intervention effects, the SMASH program office decided to organize a final evaluation of the program in the whole province in 2016, and quantitative data collection in June and July 2016.
- Conditions
- Hypertension
- Keywords
- Evaluation, Population-based Intervention, Salt intake, Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypertension
Two blood pressure (BP) measurements were obtained using a standardized mercury sphygmomanometer after a 5-min seated rest and information on history of hypertension was obtained using a standard questionnaire. Hypertension was defined as mean systolic BP (SBP) at least 140 mmHg and/or diastolic BP (DBP) at least 90 mmHg, and/or self-reported current use of antihypertensive medication.
Measured: June-July 2016
Awareness, treatment, and control of hypertension
Caculate the proportion of people reported having hypertension, the proportion of people reported taking medication and the proportion of them had their blood presure controlled (<140/<90 mmHg) among those classified as having hypertension.
Measured: June-July 2016
Salt intake related awareness, belief and behavior
A face to face, close-ended questionnaire was administered by trained public health professionals. Questions collected information on: knowledge, attitudes and practices related to sodium and hypertension (relationship between sodium and hypertension, consequences of hypertension, perception of salt consumption, self-reported consumption, intention to reduce salt consumption, and practices towards reducing sodium consumption). Then caculate the KAP rates.
Measured: June-July 2016
Salt intake
All participants were given written and verbal instructions to collect a 24 h urine sample. The samples were first assayed for creatinine concentration using the picric acid method (ADICON Clinical Laboratory; CAP accredited). The sodium concentration was determined using the direction selective electrode method. Daily salt intake was estimated by assessing 24h urinary sodium excretion based on the assumption that all sodium was ingested in the form of sodium chloride.
Measured: June-July 2016
Salt sources
Determined by respondents filling 72-hour dietary recall questionnaires. Furthermore, the survey team asks district/county salt companies to submit sales volumes of different salt products in 2011-2015 for statistics.
Measured: June-July 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 17,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Shandong Province Centers for Disease Control and Prevention, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Ma Jixiang, Centers for Disease Control and Prevention, China
- Investigators
- Ma Jixiang, MD, Principal investigator, The National Center for Chronic and Noncommunicable Disease Control and Prevention(NCNCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296332
- Sponsor's protocol ID
- 2012GSF11828
- Acronym
- SMASH
- Status last verified
- Sep 2017
- First submitted
- 31 May 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang J, Xu AQ, Ma JX, Shi XM, Guo XL, Engelgau M, Yan LX, Li Y, Li YC, Wang HC, Lu ZL, Zhang JY, Liang XF. Dietary sodium intake: knowledge, attitudes and practices in Shandong Province, China, 2011. PLoS One. 2013;8(3):e58973. doi: 10.1371/journal.pone.0058973. Epub 2013 Mar 18.
PubMed 23527061Bi Z, Liang X, Xu A, Wang L, Shi X, Zhao W, Ma J, Guo X, Zhang X, Zhang J, Ren J, Yan L, Lu Z, Wang H, Tang J, Cai X, Dong J, Zhang J, Chu J, Engelgau M, Yang Q, Hong Y, Wang Y. Hypertension prevalence, awareness, treatment, and control and sodium intake in Shandong Province, China: baseline results from Shandong-Ministry of Health Action on Salt Reduction and Hypertension (SMASH), 2011. Prev Chronic Dis. 2014 May 22;11:E88. doi: 10.5888/pcd11.130423.
PubMed 24854239Xu J, Wang M, Chen Y, Zhen B, Li J, Luan W, Ning F, Liu H, Ma J, Ma G. Estimation of salt intake by 24-hour urinary sodium excretion: a cross-sectional study in Yantai, China. BMC Public Health. 2014 Feb 8;14:136. doi: 10.1186/1471-2458-14-136.
PubMed 24507470Zhang JY, Yan LX, Tang JL, Ma JX, Guo XL, Zhao WH, Zhang XF, Li JH, Chu J, Bi ZQ. Estimating daily salt intake based on 24 h urinary sodium excretion in adults aged 18-69 years in Shandong, China. BMJ Open. 2014 Jul 18;4(7):e005089. doi: 10.1136/bmjopen-2014-005089.
PubMed 25037642Yan L, Ma J, Guo X, Tang J, Zhang J, Lu Z, Wang H, Cai X, Wang L. Urinary albumin excretion and prevalence of microalbuminuria in a general Chinese population: a cross-sectional study. BMC Nephrol. 2014 Oct 13;15:165. doi: 10.1186/1471-2369-15-165.
PubMed 25308236Li JH, Xu AQ, Lu ZL, Yan LX, Guo XL, Wang HC, Ma JX, Zhang JY, Dong J, Wang LH. Dietary sodium intake and its impact factors in adults of Shandong province. Biomed Environ Sci. 2014 Jul;27(7):564-6. doi: 10.3967/bes2014.087.
PubMed 25073917Ge Z, Guo X, Chen X, Zhang J, Yan L, Tang J, Cai X, Xu A, Ma J. Are Microalbuminuria and Elevated 24 H Urinary Microalbumin Excretion within Normal Range Associated with Metabolic Syndrome in Chinese Adults? PLoS One. 2015 Sep 17;10(9):e0138410. doi: 10.1371/journal.pone.0138410. eCollection 2015.
PubMed 26379278Chen X, Guo X, Ma J, Zhang J, Tang J, Yan L, Xu C, Zhang X, Ren J, Lu Z, Zhang G, Dong J, Xu A. Urinary sodium or potassium excretion and blood pressure in adults of Shandong province, China: preliminary results of the SMASH project. J Am Soc Hypertens. 2015 Oct;9(10):754-762. doi: 10.1016/j.jash.2015.07.004. Epub 2015 Jul 26.
PubMed 26302666Ge Z, Zhang J, Chen X, Yan L, Guo X, Lu Z, Xu A, Ma J. Are 24 h urinary sodium excretion and sodium:potassium independently associated with obesity in Chinese adults? Public Health Nutr. 2016 Apr;19(6):1074-80. doi: 10.1017/S136898001500230X. Epub 2015 Jul 31.
PubMed 26228639Yan L, Bi Z, Tang J, Wang L, Yang Q, Guo X, Cogswell ME, Zhang X, Hong Y, Engelgau M, Zhang J, Elliott P, Angell SY, Ma J. Relationships Between Blood Pressure and 24-Hour Urinary Excretion of Sodium and Potassium by Body Mass Index Status in Chinese Adults. J Clin Hypertens (Greenwich). 2015 Dec;17(12):916-25. doi: 10.1111/jch.12658. Epub 2015 Aug 29.
PubMed 26332433Zhang J, Guo XL, Seo DC, Xu AQ, Xun PC, Ma JX, Shi XM, Li N, Yan LX, Li Y, Lu ZL, Zhang JY, Tang JL, Ren J, Zhao WH, Liang XF. Inaccuracy of Self-reported Low Sodium Diet among Chinese: Findings from Baseline Survey for Shandong & Ministry of Health Action on Salt and Hypertension (SMASH) Project. Biomed Environ Sci. 2015 Feb;28(2):161-7. doi: 10.3967/bes2015.022.
PubMed 25716570
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shandong and Ministry of Health Action on Salt and Hypertension Project (SMASH)
- ClinicalTrials.gov ID
- NCT03296332
- Acronym / sponsor ID
- SMASH / 2012GSF11828
- Conditions
- Hypertension
- Keywords
- Evaluation, Population-based Intervention, Salt intake, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,160 participants (estimated)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Shandong Province Centers for Disease Control and Prevention, Centers for Disease Control and Prevention
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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.
This final evaluation intends to evaluate SMASH implementation outcomes and intervention effects through quantitative and qualitative assessment, and provide evidence for the national government to develop salt-reduction and blood-pressure lowering strategies in large scales.
Detailed description
Every year, about 1.65 million people die of excessive salt intake in the world as excessive sodium will raise blood pressure, which further increase prevalence risks of cardiovascular and kidney diseases. Therefore, reducing salt intake has been recognized as one of the most cost-effective measures for health improvement. Adopting critical salt-reduction measures can substantially reduce prevalence risks of cardiovascular and other chronic diseases. In this sense, exploring salt-reduction strategies that are widely effective among populations is critical for prevention and management of cardiovascular diseases.
The daily salt intake currently recommended by WHO is 5g (6g is recommended by Chinese government). It is estimated that 2.50 million people will not die each year if the global salt consumption is lowered to the recommended level. WHO member countries have reached an agreement to reduce 30% of the salt intake of people across the world by 2025. However, there are not enough study evidence and practical foundation for achieving the salt-reduction goal among all human beings.
Shandong is a large Chinese province with 96.85 million permanent population in its 138 counties (districts) and 62,719 communities (villages or municipal neighborhood communities). Shandong has high prevalences of cardiovascular diseases with an adult hypertensive prevalence above the national average. According to the national nutrition survey in 2002, Shandong consumed 12.6g salt per capita for daily cooking, much higher than the recommended amount (6g) in Chinese dietary guidelines. Shandong and the Ministry of Health signed a five-year cooperative agreement in 2011, Shandong-MOH Action on Salt and Hypertension ("SMASH"). The program has adopted multi-angle and multi-level intervention strategies to reduce salt intake by people for the purpose of preventing hypertension and other diseases related to salt.
SMASH baseline survey in 2011 studied 15,350 people aged 18-69 by regions and towns with multi-stage cluster random sampling to investigate their blood pressures and conditions. The survey showed that hypertensive prevalence, awareness, treatment and control rates were 23.4%, 34.5%, 27.5%, 14.9% respectively. In the baseline survey, 24-hour urine of 2,112 people was collected, and a salt intake of 13.8g per person per day was obtained in accordance with the urinary sodium data.
Since the commencement of the program, Shandong provincial government has cooperated with relevant departments to establish a work mechanism that is led by MOH, implemented by professional institutes and extensively engaged by the whole society. The program team has developed food standards and regulations and promoted salt-reduction actions in catering entities, supermarkets and food processing enterprises for a favorable environment of the program. The program team has prepared various publicity materials, and trained key groups (catering workers, food manufacturers, housewives and elementary school students). Salt consumption monitoring points and cardiovascular prevalence monitoring system have been established.
SMASH will conclude in May 2016. In order to assess the intervention course, implementation outcomes and intervention effects, the SMASH program office decided to organize a final evaluation of the program in the whole province in 2016, and quantitative data collection in June and July 2016.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Respondents are permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages), but those with severe physical or mental diseases can't participate. The survey is conducted at the same time as the SMASH baseline survey in June-July 2016. Basic demographic information, disease information, hypertension risk elements, knowledge of salt and hypertension, belief and behavior of respondents will be objectively collected and recorded through questionnaires by trained investigators from respondents. The respondents aged 18-69 are sampled from villages and urban neighborhood communities, while those aged 6-17 are sampled from schools.
Key inclusion criteria (1 listed)
- Permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages).
Key exclusion criteria (7 listed)
- Residents with severe physical or mental diseases.
- Urine can't be collected due to aconuresis;
- The candidate has difficulty to collect urine and can't find an assistant;
- Patients with acute/chronic urinary tract infection, vaginal infection and perianal infection;
- Patients with acute hemorrhagic diseases in urinary tract, vagina and digestive tract;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of hypertension
Time frame: June-July 2016
Two blood pressure (BP) measurements were obtained using a standardized mercury sphygmomanometer after a 5-min seated rest and information on history of hypertension was obtained using a standard questionnaire. Hypertension was defined as mean systolic BP (SBP) at least 140 mmHg and/or diastolic BP (DBP) at least 90 mmHg, and/or self-reported current use of antihypertensive medication.
Awareness, treatment, and control of hypertension
Time frame: June-July 2016
Caculate the proportion of people reported having hypertension, the proportion of people reported taking medication and the proportion of them had their blood presure controlled (<140/<90 mmHg) among those classified as having hypertension.
Salt intake related awareness, belief and behavior
Time frame: June-July 2016
A face to face, close-ended questionnaire was administered by trained public health professionals. Questions collected information on: knowledge, attitudes and practices related to sodium and hypertension (relationship between sodium and hypertension, consequences of hypertension, perception of salt consumption, self-reported consumption, intention to reduce salt consumption, and practices towards reducing sodium consumption). Then caculate the KAP rates.
Salt intake
Time frame: June-July 2016
All participants were given written and verbal instructions to collect a 24 h urine sample. The samples were first assayed for creatinine concentration using the picric acid method (ADICON Clinical Laboratory; CAP accredited). The sodium concentration was determined using the direction selective electrode method. Daily salt intake was estimated by assessing 24h urinary sodium excretion based on the assumption that all sodium was ingested in the form of sodium chloride.
Salt sources
Time frame: June-July 2016
Determined by respondents filling 72-hour dietary recall questionnaires. Furthermore, the survey team asks district/county salt companies to submit sales volumes of different salt products in 2011-2015 for statistics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Results publication: PubMed 23527061Zhang J, Xu AQ, Ma JX, Shi XM, Guo XL, Engelgau M, Yan LX, Li Y, Li YC, Wang HC, Lu ZL, Zhang JY, Liang XF. Dietary sodium intake: knowledge, attitudes and practices in Shandong Province, China, 2011. PLoS One. 2013;8(3):e58973. doi: 10.1371/journal.pone.0058973. Epub 2013 Mar 18.
- Results publication: PubMed 24854239Bi Z, Liang X, Xu A, Wang L, Shi X, Zhao W, Ma J, Guo X, Zhang X, Zhang J, Ren J, Yan L, Lu Z, Wang H, Tang J, Cai X, Dong J, Zhang J, Chu J, Engelgau M, Yang Q, Hong Y, Wang Y. Hypertension prevalence, awareness, treatment, and control and sodium intake in Shandong Province, China: baseline results from Shandong-Ministry of Health Action on Salt Reduction and Hypertension (SMASH), 2011. Prev Chronic Dis. 2014 May 22;11:E88. doi: 10.5888/pcd11.130423.
- Results publication: PubMed 24507470Xu J, Wang M, Chen Y, Zhen B, Li J, Luan W, Ning F, Liu H, Ma J, Ma G. Estimation of salt intake by 24-hour urinary sodium excretion: a cross-sectional study in Yantai, China. BMC Public Health. 2014 Feb 8;14:136. doi: 10.1186/1471-2458-14-136.
- Results publication: PubMed 25037642Zhang JY, Yan LX, Tang JL, Ma JX, Guo XL, Zhao WH, Zhang XF, Li JH, Chu J, Bi ZQ. Estimating daily salt intake based on 24 h urinary sodium excretion in adults aged 18-69 years in Shandong, China. BMJ Open. 2014 Jul 18;4(7):e005089. doi: 10.1136/bmjopen-2014-005089.
- Results publication: PubMed 25308236Yan L, Ma J, Guo X, Tang J, Zhang J, Lu Z, Wang H, Cai X, Wang L. Urinary albumin excretion and prevalence of microalbuminuria in a general Chinese population: a cross-sectional study. BMC Nephrol. 2014 Oct 13;15:165. doi: 10.1186/1471-2369-15-165.
- Results publication: PubMed 25073917Li JH, Xu AQ, Lu ZL, Yan LX, Guo XL, Wang HC, Ma JX, Zhang JY, Dong J, Wang LH. Dietary sodium intake and its impact factors in adults of Shandong province. Biomed Environ Sci. 2014 Jul;27(7):564-6. doi: 10.3967/bes2014.087.
- Results publication: PubMed 26379278Ge Z, Guo X, Chen X, Zhang J, Yan L, Tang J, Cai X, Xu A, Ma J. Are Microalbuminuria and Elevated 24 H Urinary Microalbumin Excretion within Normal Range Associated with Metabolic Syndrome in Chinese Adults? PLoS One. 2015 Sep 17;10(9):e0138410. doi: 10.1371/journal.pone.0138410. eCollection 2015.
- Results publication: PubMed 26302666Chen X, Guo X, Ma J, Zhang J, Tang J, Yan L, Xu C, Zhang X, Ren J, Lu Z, Zhang G, Dong J, Xu A. Urinary sodium or potassium excretion and blood pressure in adults of Shandong province, China: preliminary results of the SMASH project. J Am Soc Hypertens. 2015 Oct;9(10):754-762. doi: 10.1016/j.jash.2015.07.004. Epub 2015 Jul 26.
- Results publication: PubMed 26228639Ge Z, Zhang J, Chen X, Yan L, Guo X, Lu Z, Xu A, Ma J. Are 24 h urinary sodium excretion and sodium:potassium independently associated with obesity in Chinese adults? Public Health Nutr. 2016 Apr;19(6):1074-80. doi: 10.1017/S136898001500230X. Epub 2015 Jul 31.
- Results publication: PubMed 26332433Yan L, Bi Z, Tang J, Wang L, Yang Q, Guo X, Cogswell ME, Zhang X, Hong Y, Engelgau M, Zhang J, Elliott P, Angell SY, Ma J. Relationships Between Blood Pressure and 24-Hour Urinary Excretion of Sodium and Potassium by Body Mass Index Status in Chinese Adults. J Clin Hypertens (Greenwich). 2015 Dec;17(12):916-25. doi: 10.1111/jch.12658. Epub 2015 Aug 29.
- Results publication: PubMed 25716570Zhang J, Guo XL, Seo DC, Xu AQ, Xun PC, Ma JX, Shi XM, Li N, Yan LX, Li Y, Lu ZL, Zhang JY, Tang JL, Ren J, Zhao WH, Liang XF. Inaccuracy of Self-reported Low Sodium Diet among Chinese: Findings from Baseline Survey for Shandong & Ministry of Health Action on Salt and Hypertension (SMASH) Project. Biomed Environ Sci. 2015 Feb;28(2):161-7. doi: 10.3967/bes2015.022.
- Individual participant dataSharing planned: No
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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.
Ma Jixiang, MD principal investigator
The National Center for Chronic and Noncommunicable Disease Control and Prevention(NCNCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Centers for Disease Control and Prevention, 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2017. 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?
Results are not available in the source record.
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?
Prevalence of hypertension (time frame: June-July 2016). The study lists 5 primary outcomes in all. 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 NCT03296332, which also lists 11 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 28 Sep 2017.