CKD ProgressionNCT05716386
Effect of Low Salt and Ckd Progression
A study testing Low salt diet in people with CKD Progression and Blood Pressure, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial summary
Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CKD Progression, Blood Pressure, Proteinuria
- What is being tested?
- Low salt diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 28 Feb 2023to 31 Aug 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- years with CKD stage 1-3 (estimated glomerular filtration rate (eGFR) of 30-59 ml/min per 1·73 m2
- No recent history of acute illness or hospitalization
- BP >135/85 mmHg or controlled BP with the use of antihypertensive medications.
Who cannot join
- Serious primary diseases affecting major organs such as the heart, brain, lung, liver, or hematopoietic system
- Active cancers
- Acute infectious diseases
- Pregnancy
- Post solid organs transplantation
- Terminally ill.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine,Vajira Hospital,Navamindradhiraj University
Bangkok, 10300
About this study
Official title: The Effect of Low Salt Diet on CKD Progression:A Randomized Controlled Trial
Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study
Read the detailed description
The prevalence of non-communicable disease (NCD including cardiovascular disease (CVD), diabetes mellitus (DM),hypertension(HT) and chronic kidney disease(CKD) continues to rise all over the world and lead to global crisis.The world Health Organization (WHO) shows that more than 50% of the burden of diseases arise from NCD and 30% is attributed to CVD[1] .In Thailand,the prevalence of high blood pressure in population age > 15 is increasing in the past 10 years .In 2022 the HT prevalence was 21.4 and the admission rate of CVD increased from 109.4 to 793.3 per 100,000 population [2]. Cumulating evidence highlights that higher sodium consumption contributes to higher BP [3], thus increasing the risk of cardiovascular disease (CVD) [4,5]. According to the World Health Organization, the restriction of sodium intake to less than 2.3 g/day of sodium corresponding to 5.8 g of salt (or 100 mmol) is one of the most cost-effective measures to improve public health [6]. In particular, in a large cohort study in over 100,000 patients from 18 countries the role of higher salt consumption was associated with increased BP levels [7], and poor CV outcomes [8].In one meta-analysis ,reduce salt intake to 1,800 mg per day will help reduce blood pressure by 2/1 mmHg in non-hypertensive cohorts and 5/2.7 mmHg in hypertensive patients [4].In fact, even minor sodium restriction for only 700-800 mmol/day was associated with reduction of CVD and mortality risks for 20 and 5-7% respectively.
A long-standing line of evidence also shows beneficial effects of salt reduction in patients with chronic kidney disease (CKD) as well as in healthy people [9,10]. A recent review of the evidence for the relationship between salt intake and CKD progression concluded there is consistent evidence to suggest that dietary salt intake is linked with albuminuria and tissue injury [9] [11]. High salt intake is closely associated with the progression of CKD. When the urine sodium-to-creatinine ratio increases by 100 mmol/L, the risk of CKD developing into end-stage renal disease (ESRD) increases by 1.61 times [12,13]. High salt intake leads to renal impairment in various ways, including increasing transforming growth factor (TGF)-β1 production and enhancing oxidative stress and inflammatory response kidney [14-16]. The Lowsalt CKD trial trials had shown that in patients with CKD, salt reduction will have additional beneficial effects on renal effects, reduction of proteinuria,independent of blood pressure lowering effect. reported that salt reduction helped control blood pressure,reduce proteinuria [17] .However,the follow up time was too short. Meta-analysis data from Garofalo et al [18] indicates that low sodium intake ( 4.4 gm/day) in 738 CKD patients from 9 studies significantly reduce systolic blood pressure by 4.9 mmHg (95%CI 6.8/31 mmHg, p <0.001) .The diastolic blood pressure also reduce by 2 mmHg (95%CI 6.8/3.1 mmHg, P<0.001) .In CRIC study[19] which followed a cohort of 3,757 CKD patients for nearly 7 years,the authors found that the high urine sodium group (UNaV > 195 mmoL/day) significantly increased risk for CKD progression and CVD risk. These data support the evidence that reducing dietary sodium can reduce cardiovascular risk and rate of CKD progression.
However, restriction in dietary sodium intake also activates the renin-angiotensin -aldosterone system (RAAS) and sympathetic nervous system[20,21].Low dietary sodium has been reported to be associated with insulin resistance [22]. To date, the connection between sodium intake and CKD progression provided inconsistent results [23]. Although several studies have shown that high dietary sodium intake increases the risk of CKD development or progression [24-26], some results failed to find significant connections to renal outcome [27-30]. In addition, there have also been reports that lower 24-hour urine sodium excretion is associated with higher risk of death and ESRD in individuals with type 1 and type 2 diabetes with overt proteinuria [30,31]. Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study
- Conditions
- CKD Progression, Blood Pressure, Proteinuria
- Being tested
- Low salt diet
- Keywords
- CKD progression, Low salt, Randomized controlled trial
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salt dietDietary supplement
Low salt diet less than 2 gram per day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The low sodium diet will be provided low salt diet 1.5 gm/day in three main meals for three months.The food will be provided by the nutritionists and delivered directly to their home Receives: Dietary Supplement: Low salt diet |
| Control | Placebo comparator | The control group will continue with their usual diet and record the food recall Receives: Dietary Supplement: Low salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of GFR decline
estimeated glomerular filtration rate
Measured: 3 months
Secondary outcomes (4)
Blood pressure status
Blood pressure
Measured: 3 months
Acid-base status
Electrolyte level
Measured: 3 months
Calcium-phosphate balance
calcium,phosphorus level
Measured: 3 months
Proteinuria
24 hour urine protien level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start28 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for CKD ProgressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open labelled randomized controlled trial study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Collaborators
- Science research and innovation
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvanich, Principal investigator, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716386
- Sponsor's protocol ID
- 142/65
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to deposit the data to the central repository site such as figshare or Mendeley
Publications
Cappuccio FP, Capewell S, Lincoln P, McPherson K. Policy options to reduce population salt intake. BMJ. 2011 Aug 11;343:d4995. doi: 10.1136/bmj.d4995. No abstract available.
PubMed 21835876Garofalo C, Borrelli S, Provenzano M, De Stefano T, Vita C, Chiodini P, Minutolo R, De Nicola L, Conte G. Dietary Salt Restriction in Chronic Kidney Disease: A Meta-Analysis of Randomized Clinical Trials. Nutrients. 2018 Jun 6;10(6):732. doi: 10.3390/nu10060732.
PubMed 29882800He J, Mills KT, Appel LJ, Yang W, Chen J, Lee BT, Rosas SE, Porter A, Makos G, Weir MR, Hamm LL, Kusek JW; Chronic Renal Insufficiency Cohort Study Investigators. Urinary Sodium and Potassium Excretion and CKD Progression. J Am Soc Nephrol. 2016 Apr;27(4):1202-12. doi: 10.1681/ASN.2015010022. Epub 2015 Sep 17.
PubMed 26382905Rhee OJ, Rhee MY, Oh SW, Shin SJ, Gu N, Nah DY, Kim SW, Lee JH. Effect of sodium intake on renin level: Analysis of general population and meta-analysis of randomized controlled trials. Int J Cardiol. 2016 Jul 15;215:120-6. doi: 10.1016/j.ijcard.2016.04.109. Epub 2016 Apr 14.
PubMed 27111173Graudal NA, Galloe AM, Garred P. Effects of sodium restriction on blood pressure, renin, aldosterone, catecholamines, cholesterols, and triglyceride: a meta-analysis. JAMA. 1998 May 6;279(17):1383-91. doi: 10.1001/jama.279.17.1383.
PubMed 9582047McQuarrie EP, Traynor JP, Taylor AH, Freel EM, Fox JG, Jardine AG, Mark PB. Association between urinary sodium, creatinine, albumin, and long-term survival in chronic kidney disease. Hypertension. 2014 Jul;64(1):111-7. doi: 10.1161/HYPERTENSIONAHA.113.03093. Epub 2014 Apr 14.
PubMed 24732890Vegter S, Perna A, Postma MJ, Navis G, Remuzzi G, Ruggenenti P. Sodium intake, ACE inhibition, and progression to ESRD. J Am Soc Nephrol. 2012 Jan;23(1):165-73. doi: 10.1681/ASN.2011040430. Epub 2011 Dec 1.
PubMed 22135311Mazarova A, Molnar AO, Akbari A, Sood MM, Hiremath S, Burns KD, Ramsay TO, Mallick R, Knoll GA, Ruzicka M. The association of urinary sodium excretion and the need for renal replacement therapy in advanced chronic kidney disease: a cohort study. BMC Nephrol. 2016 Sep 5;17(1):123. doi: 10.1186/s12882-016-0338-z.
PubMed 27596141Nagata T, Sobajima H, Ohashi N, Hirakawa A, Katsuno T, Yasuda Y, Matsuo S, Tsuboi N, Maruyama S. Association between 24h Urinary Sodium and Potassium Excretion and Estimated Glomerular Filtration Rate (eGFR) Decline or Death in Patients with Diabetes Mellitus and eGFR More than 30 ml/min/1.73m2. PLoS One. 2016 May 2;11(5):e0152306. doi: 10.1371/journal.pone.0152306. eCollection 2016.
PubMed 27136292Thomas MC, Moran J, Forsblom C, Harjutsalo V, Thorn L, Ahola A, Waden J, Tolonen N, Saraheimo M, Gordin D, Groop PH; FinnDiane Study Group. The association between dietary sodium intake, ESRD, and all-cause mortality in patients with type 1 diabetes. Diabetes Care. 2011 Apr;34(4):861-6. doi: 10.2337/dc10-1722. Epub 2011 Feb 9.
PubMed 21307382Strong K, Mathers C, Leeder S, Beaglehole R. Preventing chronic diseases: how many lives can we save? Lancet. 2005 Oct 29-Nov 4;366(9496):1578-82. doi: 10.1016/S0140-6736(05)67341-2.
PubMed 16257345World Health Organization. Country Office for T. Hypertension care in Thailand: best practices and challenges, 2019. Bangkok: World Health Organization. Country Office for Thailand; 2019.
He FJ, Li J, Macgregor GA. Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomised trials. BMJ. 2013 Apr 3;346:f1325. doi: 10.1136/bmj.f1325.
PubMed 23558162He FJ, MacGregor GA. Salt reduction lowers cardiovascular risk: meta-analysis of outcome trials. Lancet. 2011 Jul 30;378(9789):380-2. doi: 10.1016/S0140-6736(11)61174-4. No abstract available.
PubMed 21803192Strazzullo P, D'Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009 Nov 24;339:b4567. doi: 10.1136/bmj.b4567.
PubMed 19934192
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Salt Diet on CKD Progression:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05716386
- Acronym / sponsor ID
- 142/65
- Conditions
- CKD Progression, Blood Pressure, Proteinuria
- Keywords
- CKD progression, Low salt, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Collaborators
- Science research and innovation
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Feb 2023 (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.
Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study
Detailed description
The prevalence of non-communicable disease (NCD including cardiovascular disease (CVD), diabetes mellitus (DM),hypertension(HT) and chronic kidney disease(CKD) continues to rise all over the world and lead to global crisis.The world Health Organization (WHO) shows that more than 50% of the burden of diseases arise from NCD and 30% is attributed to CVD[1] .In Thailand,the prevalence of high blood pressure in population age > 15 is increasing in the past 10 years .In 2022 the HT prevalence was 21.4 and the admission rate of CVD increased from 109.4 to 793.3 per 100,000 population [2]. Cumulating evidence highlights that higher sodium consumption contributes to higher BP [3], thus increasing the risk of cardiovascular disease (CVD) [4,5]. According to the World Health Organization, the restriction of sodium intake to less than 2.3 g/day of sodium corresponding to 5.8 g of salt (or 100 mmol) is one of the most cost-effective measures to improve public health [6]. In particular, in a large cohort study in over 100,000 patients from 18 countries the role of higher salt consumption was associated with increased BP levels [7], and poor CV outcomes [8].In one meta-analysis ,reduce salt intake to 1,800 mg per day will help reduce blood pressure by 2/1 mmHg in non-hypertensive cohorts and 5/2.7 mmHg in hypertensive patients [4].In fact, even minor sodium restriction for only 700-800 mmol/day was associated with reduction of CVD and mortality risks for 20 and 5-7% respectively.
A long-standing line of evidence also shows beneficial effects of salt reduction in patients with chronic kidney disease (CKD) as well as in healthy people [9,10]. A recent review of the evidence for the relationship between salt intake and CKD progression concluded there is consistent evidence to suggest that dietary salt intake is linked with albuminuria and tissue injury [9] [11]. High salt intake is closely associated with the progression of CKD. When the urine sodium-to-creatinine ratio increases by 100 mmol/L, the risk of CKD developing into end-stage renal disease (ESRD) increases by 1.61 times [12,13]. High salt intake leads to renal impairment in various ways, including increasing transforming growth factor (TGF)-β1 production and enhancing oxidative stress and inflammatory response kidney [14-16]. The Lowsalt CKD trial trials had shown that in patients with CKD, salt reduction will have additional beneficial effects on renal effects, reduction of proteinuria,independent of blood pressure lowering effect. reported that salt reduction helped control blood pressure,reduce proteinuria [17] .However,the follow up time was too short. Meta-analysis data from Garofalo et al [18] indicates that low sodium intake ( 4.4 gm/day) in 738 CKD patients from 9 studies significantly reduce systolic blood pressure by 4.9 mmHg (95%CI 6.8/31 mmHg, p <0.001) .The diastolic blood pressure also reduce by 2 mmHg (95%CI 6.8/3.1 mmHg, P<0.001) .In CRIC study[19] which followed a cohort of 3,757 CKD patients for nearly 7 years,the authors found that the high urine sodium group (UNaV > 195 mmoL/day) significantly increased risk for CKD progression and CVD risk. These data support the evidence that reducing dietary sodium can reduce cardiovascular risk and rate of CKD progression.
However, restriction in dietary sodium intake also activates the renin-angiotensin -aldosterone system (RAAS) and sympathetic nervous system[20,21].Low dietary sodium has been reported to be associated with insulin resistance [22]. To date, the connection between sodium intake and CKD progression provided inconsistent results [23]. Although several studies have shown that high dietary sodium intake increases the risk of CKD development or progression [24-26], some results failed to find significant connections to renal outcome [27-30]. In addition, there have also been reports that lower 24-hour urine sodium excretion is associated with higher risk of death and ESRD in individuals with type 1 and type 2 diabetes with overt proteinuria [30,31]. Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective open labelled randomized controlled trial study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Low salt dietThe low sodium diet will be provided low salt diet 1.5 gm/day in three main meals for three months.The food will be provided by the nutritionists and delivered directly to their home |
| Control | Placebo comparator | Dietary Supplement: Low salt dietThe control group will continue with their usual diet and record the food recall |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- years with CKD stage 1-3 (estimated glomerular filtration rate (eGFR) of 30-59 ml/min per 1·73 m2
- No recent history of acute illness or hospitalization
- BP >135/85 mmHg or controlled BP with the use of antihypertensive medications.
Key exclusion criteria (6 listed)
- Serious primary diseases affecting major organs such as the heart, brain, lung, liver, or hematopoietic system
- Active cancers
- Acute infectious diseases
- Pregnancy
- Post solid organs transplantation
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 |
|---|---|---|
| Low salt dietLow salt diet less than 2 gram per day | Dietary supplement | Control, Intervention |
Primary outcome
Rate of GFR decline
Time frame: 3 months
estimeated glomerular filtration rate
4 secondary outcomes
Blood pressure status
Time frame: 3 months
Acid-base status
Time frame: 3 months
Calcium-phosphate balance
Time frame: 3 months
Proteinuria
Time frame: 3 months
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 1 Sep 2023.
- Background: PubMed 21835876Cappuccio FP, Capewell S, Lincoln P, McPherson K. Policy options to reduce population salt intake. BMJ. 2011 Aug 11;343:d4995. doi: 10.1136/bmj.d4995. No abstract available.
- Background: PubMed 29882800Garofalo C, Borrelli S, Provenzano M, De Stefano T, Vita C, Chiodini P, Minutolo R, De Nicola L, Conte G. Dietary Salt Restriction in Chronic Kidney Disease: A Meta-Analysis of Randomized Clinical Trials. Nutrients. 2018 Jun 6;10(6):732. doi: 10.3390/nu10060732.
- Background: PubMed 26382905He J, Mills KT, Appel LJ, Yang W, Chen J, Lee BT, Rosas SE, Porter A, Makos G, Weir MR, Hamm LL, Kusek JW; Chronic Renal Insufficiency Cohort Study Investigators. Urinary Sodium and Potassium Excretion and CKD Progression. J Am Soc Nephrol. 2016 Apr;27(4):1202-12. doi: 10.1681/ASN.2015010022. Epub 2015 Sep 17.
- Background: PubMed 27111173Rhee OJ, Rhee MY, Oh SW, Shin SJ, Gu N, Nah DY, Kim SW, Lee JH. Effect of sodium intake on renin level: Analysis of general population and meta-analysis of randomized controlled trials. Int J Cardiol. 2016 Jul 15;215:120-6. doi: 10.1016/j.ijcard.2016.04.109. Epub 2016 Apr 14.
- Background: PubMed 9582047Graudal NA, Galloe AM, Garred P. Effects of sodium restriction on blood pressure, renin, aldosterone, catecholamines, cholesterols, and triglyceride: a meta-analysis. JAMA. 1998 May 6;279(17):1383-91. doi: 10.1001/jama.279.17.1383.
- Background: PubMed 24732890McQuarrie EP, Traynor JP, Taylor AH, Freel EM, Fox JG, Jardine AG, Mark PB. Association between urinary sodium, creatinine, albumin, and long-term survival in chronic kidney disease. Hypertension. 2014 Jul;64(1):111-7. doi: 10.1161/HYPERTENSIONAHA.113.03093. Epub 2014 Apr 14.
- Background: PubMed 22135311Vegter S, Perna A, Postma MJ, Navis G, Remuzzi G, Ruggenenti P. Sodium intake, ACE inhibition, and progression to ESRD. J Am Soc Nephrol. 2012 Jan;23(1):165-73. doi: 10.1681/ASN.2011040430. Epub 2011 Dec 1.
- Background: PubMed 27596141Mazarova A, Molnar AO, Akbari A, Sood MM, Hiremath S, Burns KD, Ramsay TO, Mallick R, Knoll GA, Ruzicka M. The association of urinary sodium excretion and the need for renal replacement therapy in advanced chronic kidney disease: a cohort study. BMC Nephrol. 2016 Sep 5;17(1):123. doi: 10.1186/s12882-016-0338-z.
- Background: PubMed 27136292Nagata T, Sobajima H, Ohashi N, Hirakawa A, Katsuno T, Yasuda Y, Matsuo S, Tsuboi N, Maruyama S. Association between 24h Urinary Sodium and Potassium Excretion and Estimated Glomerular Filtration Rate (eGFR) Decline or Death in Patients with Diabetes Mellitus and eGFR More than 30 ml/min/1.73m2. PLoS One. 2016 May 2;11(5):e0152306. doi: 10.1371/journal.pone.0152306. eCollection 2016.
- Background: PubMed 21307382Thomas MC, Moran J, Forsblom C, Harjutsalo V, Thorn L, Ahola A, Waden J, Tolonen N, Saraheimo M, Gordin D, Groop PH; FinnDiane Study Group. The association between dietary sodium intake, ESRD, and all-cause mortality in patients with type 1 diabetes. Diabetes Care. 2011 Apr;34(4):861-6. doi: 10.2337/dc10-1722. Epub 2011 Feb 9.
- Results publication: PubMed 16257345Strong K, Mathers C, Leeder S, Beaglehole R. Preventing chronic diseases: how many lives can we save? Lancet. 2005 Oct 29-Nov 4;366(9496):1578-82. doi: 10.1016/S0140-6736(05)67341-2.
- Results publicationWorld Health Organization. Country Office for T. Hypertension care in Thailand: best practices and challenges, 2019. Bangkok: World Health Organization. Country Office for Thailand; 2019.
- Individual participant dataSharing planned: Yes. We plan to deposit the data to the central repository site such as figshare or Mendeley
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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.
Thananda Trakarnvanich principal investigator
Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low salt diet in people with CKD Progression and Blood Pressure, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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 6 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 1 Sep 2023. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Rate of GFR decline (time frame: 3 months). 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 NCT05716386, which also lists 30 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 1 Sep 2023.