Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-02-28
Study Completion Date
2023-08-31
Brief Summary
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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
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Detailed Description
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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
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
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CKD Progression
Blood Pressure
Proteinuria
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Prospective open labelled randomized controlled trial study
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Intervention
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
Group Type
EXPERIMENTAL
Low salt diet
Intervention Type
DIETARY_SUPPLEMENT
Low salt diet less than 2 gram per day
Control
The control group will continue with their usual diet and record the food recall
Group Type
PLACEBO_COMPARATOR
Low salt diet
Intervention Type
DIETARY_SUPPLEMENT
Low salt diet less than 2 gram per day
Interventions
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Low salt diet
Low salt diet less than 2 gram per day
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* 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.
* No recent history of acute illness or hospitalization
* BP \>135/85 mmHg or controlled BP with the use of antihypertensive medications.
Exclusion Criteria
* 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.
* Active cancers
* Acute infectious diseases
* Pregnancy
* Post solid organs transplantation
* Terminally ill.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Science research and innovation
UNKNOWN
Sponsor Role
collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Thananda Trakarnvanich
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Thananda Trakarnvanich
Role: PRINCIPAL_INVESTIGATOR
Navamindradhiraj University
Locations
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Faculty of Medicine,Vajira Hospital,Navamindradhiraj University
Bangkok, , Thailand
Site Status
Countries
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Thailand
References
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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.
Reference Type
BACKGROUND
Garofalo 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.
Reference Type
BACKGROUND
He 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.
Reference Type
BACKGROUND
Rhee 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.
Reference Type
BACKGROUND
Graudal 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.
Reference Type
BACKGROUND
McQuarrie 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.
Reference Type
BACKGROUND
Vegter 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.
Reference Type
BACKGROUND
Mazarova 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.
Reference Type
BACKGROUND
Nagata 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.
Reference Type
BACKGROUND
Thomas 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.
Reference Type
BACKGROUND
Strong 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.
Reference Type
RESULT
World Health Organization. Country Office for T. Hypertension care in Thailand: best practices and challenges, 2019. Bangkok: World Health Organization. Country Office for Thailand; 2019.
Reference Type
RESULT
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.
Reference Type
RESULT
He 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.
Reference Type
RESULT
Strazzullo 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.
Reference Type
RESULT
Guideline: Sodium Intake for Adults and Children. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK133309/
Reference Type
RESULT
Mente A, O'Donnell MJ, Rangarajan S, McQueen MJ, Poirier P, Wielgosz A, Morrison H, Li W, Wang X, Di C, Mony P, Devanath A, Rosengren A, Oguz A, Zatonska K, Yusufali AH, Lopez-Jaramillo P, Avezum A, Ismail N, Lanas F, Puoane T, Diaz R, Kelishadi R, Iqbal R, Yusuf R, Chifamba J, Khatib R, Teo K, Yusuf S; PURE Investigators. Association of urinary sodium and potassium excretion with blood pressure. N Engl J Med. 2014 Aug 14;371(7):601-11. doi: 10.1056/NEJMoa1311989.
Reference Type
RESULT
Hooper L, Bartlett C, Davey Smith G, Ebrahim S. Systematic review of long term effects of advice to reduce dietary salt in adults. BMJ. 2002 Sep 21;325(7365):628. doi: 10.1136/bmj.325.7365.628.
Reference Type
RESULT
Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, Woodward M, MacMahon S, Turnbull F, Hillis GS, Chalmers J, Mant J, Salam A, Rahimi K, Perkovic V, Rodgers A. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016 Jan 30;387(10017):435-43. doi: 10.1016/S0140-6736(15)00805-3. Epub 2015 Nov 7.
Reference Type
RESULT
Yuan M, Moody WE, Townend JN. Central blood pressure in chronic kidney disease: latest evidence and clinical relevance. Curr Hypertens Rev. 2014;10(2):99-106. doi: 10.2174/1573402111666141231145931.
Reference Type
RESULT
Jones-Burton C, Mishra SI, Fink JC, Brown J, Gossa W, Bakris GL, Weir MR. An in-depth review of the evidence linking dietary salt intake and progression of chronic kidney disease. Am J Nephrol. 2006;26(3):268-75. doi: 10.1159/000093833. Epub 2006 Jun 9.
Reference Type
RESULT
O'Donnell M, Mente A, Rangarajan S, McQueen MJ, Wang X, Liu L, Yan H, Lee SF, Mony P, Devanath A, Rosengren A, Lopez-Jaramillo P, Diaz R, Avezum A, Lanas F, Yusoff K, Iqbal R, Ilow R, Mohammadifard N, Gulec S, Yusufali AH, Kruger L, Yusuf R, Chifamba J, Kabali C, Dagenais G, Lear SA, Teo K, Yusuf S; PURE Investigators. Urinary sodium and potassium excretion, mortality, and cardiovascular events. N Engl J Med. 2014 Aug 14;371(7):612-23. doi: 10.1056/NEJMoa1311889.
Reference Type
RESULT
Habibi J, Hayden MR, Ferrario CM, Sowers JR, Whaley-Connell AT. Salt Loading Promotes Kidney Injury via Fibrosis in Young Female Ren2 Rats. Cardiorenal Med. 2014 Apr;4(1):43-52. doi: 10.1159/000360866. Epub 2014 Mar 14.
Reference Type
RESULT
Varagic J, Ahmad S, Brosnihan KB, Habibi J, Tilmon RD, Sowers JR, Ferrario CM. Salt-induced renal injury in spontaneously hypertensive rats: effects of nebivolol. Am J Nephrol. 2010;32(6):557-66. doi: 10.1159/000321471. Epub 2010 Nov 2.
Reference Type
RESULT
Garg R, Williams GH, Hurwitz S, Brown NJ, Hopkins PN, Adler GK. Low-salt diet increases insulin resistance in healthy subjects. Metabolism. 2011 Jul;60(7):965-8. doi: 10.1016/j.metabol.2010.09.005. Epub 2010 Oct 30.
Reference Type
RESULT
Anderson CA, Ix JH. Sodium reduction in CKD: suggestively hazardous or intuitively advantageous? J Am Soc Nephrol. 2013 Dec;24(12):1931-3. doi: 10.1681/ASN.2013090923. Epub 2013 Nov 7. No abstract available.
Reference Type
RESULT
Fan L, Tighiouart H, Levey AS, Beck GJ, Sarnak MJ. Urinary sodium excretion and kidney failure in nondiabetic chronic kidney disease. Kidney Int. 2014 Sep;86(3):582-8. doi: 10.1038/ki.2014.59. Epub 2014 Mar 19.
Reference Type
RESULT
Dunkler D, Dehghan M, Teo KK, Heinze G, Gao P, Kohl M, Clase CM, Mann JF, Yusuf S, Oberbauer R; ONTARGET Investigators. Diet and kidney disease in high-risk individuals with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 14;173(18):1682-92. doi: 10.1001/jamainternmed.2013.9051.
Reference Type
RESULT
Kieneker LM, Bakker SJ, de Boer RA, Navis GJ, Gansevoort RT, Joosten MM. Low potassium excretion but not high sodium excretion is associated with increased risk of developing chronic kidney disease. Kidney Int. 2016 Oct;90(4):888-96. doi: 10.1016/j.kint.2016.07.012. Epub 2016 Aug 26.
Reference Type
RESULT
Trakarnvanich T, Chailimpamontree W, Kantachuvesiri S, Anutrakulchai S, Manomaipiboon B, Ngamvitchukorn T, Suraamornkul S, Trakarnvanich T, Kurathong S. Effect of a Low Salt Diet on the Progression of Chronic Kidney Disease: A Prospective, Open-Label, Randomized Controlled Trial. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241297766. doi: 10.1177/21501319241297766.
Reference Type
DERIVED
Other Identifiers
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142/65
Identifier Type: -
Identifier Source: org_study_id
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