Effect of Low Salt and Ckd Progression

NCT05716386 | Completed DMC

• 1 other identifier: 142/65
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

CKD Progression; Blood Pressure; Proteinuria

Keywords

CKD progression; Low salt; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of GFR decline

  estimeated glomerular filtration rate

  3 months

Secondary Outcomes (4)

• Blood pressure status

  3 months

• Acid-base status

  3 months

• Calcium-phosphate balance

  3 months

• Proteinuria

  3 months

Study Arms (2)

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

Dietary Supplement: Low salt diet

Control

PLACEBO COMPARATOR

The control group will continue with their usual diet and record the food recall

Dietary Supplement: Low salt diet

Interventions

Low salt diet DIETARY_SUPPLEMENT

Low salt diet less than 2 gram per day

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead
• Science research and innovation: collaborator

Study Sites (1)

Faculty of Medicine,Vajira Hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

Location

Related Publications (30)

• 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.

  PMID: 21835876 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.

  PMID: 29882800 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.

  PMID: 26382905 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.

  PMID: 27111173 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.

  PMID: 9582047 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.

  PMID: 24732890 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.

  PMID: 22135311 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.

  PMID: 27596141 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.

  PMID: 27136292 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.

  PMID: 21307382 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.

  PMID: 16257345 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.

  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.

  PMID: 23558162 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.

  PMID: 21803192 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.

  PMID: 19934192 RESULT

• Guideline: Sodium Intake for Adults and Children. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK133309/

  PMID: 23658998 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.

  PMID: 25119606 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.

  PMID: 12242173 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.

  PMID: 26559744 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.

  PMID: 25549839 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.

  PMID: 16763384 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.

  PMID: 25119607 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.

  PMID: 24847333 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.

  PMID: 21042014 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.

  PMID: 21036373 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.

  PMID: 24204000 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.

  PMID: 24646858 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.

  PMID: 23939297 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.

  PMID: 27575557 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.

  PMID: 39526855 DERIVED

MeSH Terms

Conditions

Proteinuria

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thananda Trakarnvanich

  Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective open labelled randomized controlled trial study

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: February 28, 2023
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Indefifnitely
• Access Criteria: Investigator team member Those who get permission from the principle investigator

Locations

TH (1)