Dietary Sodium Intake and Blood Pressure in Living Kidney Donors

Hypertension Clinical Trial

— SPLID  

Official title:

Dietary Sodium Intake and Blood Pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041829
• Other study ID #: HS#2021-6478
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of California, Irvine
• Contact: Ekamol Tantisattamo, MD, MPH
• Phone: 714-456-5142
• Email: etantisa[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.

Description:

This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake <2.3 g/day (<100 mmol/day) is superior to high dietary sodium intake ≥4 - <6 g/day (≥174 - <261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation?.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Living kidney donors who underwent a living kidney donation at least 5 months ago but not more than 12 months

• Age =18 years old

• Agree to perform the procedure as per study protocol (Table 1)

• Living kidney donors with an average sitting SBP <160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)

• Able to sign informed consent

• Able to attend all research visits

• Woman using birth control methods other than hormonal contraception

Exclusion Criteria:

• History of previous cardiovascular (CV) events including acute MI, HF, and stroke

• Symptomatic heart failure within 5 months after living kidney donation or left ventricular ejection fraction (by any method) <35%

• CV event or procedure or hospitalization for hypertensive-related disorders within 5 months after living kidney donation

• Diagnosed with HTN or on antihypertensive medication(s) before living kidney donation

• Patients who are supposed to take BP lowering medications for reasons other than BP control but do not take those medications or take them with in appropriate doses

• Arm circumference is too small or large to allow accurate BP measurement with available 24-h ABPM machines.

• An average standing SBP =160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)

• Albuminuria that equals or is equivalent to 1 g per day by using spot urinary albumin per urine creatinine ratio (UACR) or 24-hour urinary albumin excretion rate by a 24-hour urine collection within 5 months post-donation

• Advanced kidney function defined by estimated glomerular filtration rate (eGFR) by using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation22 of <20 ml/min/1.73m2 or requiring dialysis after living kidney donation

• Drink coffee > two 8-ounce (237 mL) cup a day or equivalence

• Drinks alcohol >3 drinks/day or >30 ml/day

• Smoking cigarette =10 cigarettes/day

• Take Nonsteroidal anti-inflammatory drugs (NSAIDS)

• Use hormone replacement therapy or oral contraceptives

• Pregnancy, currently trying to become pregnant

• Using birth control pills

• A medical condition likely to limit survival to less than 2 years

• Any factors that are likely to limit adherence to interventions. For example,

• Living kidney donors who cannot come to follow up regularly per study protocol to logistically collect data from enrolled participants.

• Active alcohol or substance abuse within the last 5 months of living kidney donation

• Plans to move outside the clinic catchment area in the next 4 months without the ability to transfer to come to follow up at SPLID study site.

• Significant history of poor adherences with medications or attendance at clinic visits

• Significant concerns about participation in the study from spouse, significant other, or family members

• Lack of support from primary health care provider

• Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the SPLID clinic funds for screening or randomization visits

• Residence in a nursing home or an assisted living

• Clinical dementia with or without treatment with medications and cognitively unable to follow the protocol

• Other medical, psychiatric, or behavioral factors that may interfere with study participation or the ability to follow the intervention protocol

• Inability to obtain informed consent from participant

• Living in the same household as an already randomized SPLID participant

Related Conditions & MeSH terms

• Hypertension
• Living Kidney Donor

Intervention

Other:
• Dietary sodium
Low sodium diet with sodium of <2.3 g/day (<100 mmol/day) and high sodium diet with sodium of =4 - <6 g/day (=174 - <261 mmo/day)

Locations

Country	Name	City	State
United States	University of California Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (26)

Anjum S, Muzaale AD, Massie AB, Bae S, Luo X, Grams ME, Lentine KL, Garg AX, Segev DL. Patterns of End-Stage Renal Disease Caused by Diabetes, Hypertension, and Glomerulonephritis in Live Kidney Donors. Am J Transplant. 2016 Dec;16(12):3540-3547. doi: 10. — View Citation

Boudville N, Prasad GV, Knoll G, Muirhead N, Thiessen-Philbrook H, Yang RC, Rosas-Arellano MP, Housawi A, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Meta-analysis: risk for hypertension in living kidney donors. Ann Intern Med. 2006 Aug — View Citation

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8 — View Citation

Cox DR. Regression models and life tables (with discussion). Journal of the Royal Statistical Society, Series B 34, 187-220, 1972.

Davis CL, Cooper M. The state of U.S. living kidney donors. Clin J Am Soc Nephrol. 2010 Oct;5(10):1873-80. doi: 10.2215/CJN.01510210. Epub 2010 Jul 15. — View Citation

Davis CL, Delmonico FL. Living-donor kidney transplantation: a review of the current practices for the live donor. J Am Soc Nephrol. 2005 Jul;16(7):2098-110. doi: 10.1681/ASN.2004100824. Epub 2005 Jun 1. — View Citation

Gay HC, Rao SG, Vaccarino V, Ali MK. Effects of Different Dietary Interventions on Blood Pressure: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Hypertension. 2016 Apr;67(4):733-9. doi: 10.1161/HYPERTENSIONAHA.115.06853. Epub 2016 F — View Citation

Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Castro S, Foutz J, Wainright JL, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2018 Annual Data Report: Kidney. Am J Transplant. 2020 Jan;20 Suppl s1:20-130. doi: 10.1111/ajt.15672. — View Citation

Holscher CM, Haugen CE, Jackson KR, Garonzik Wang JM, Waldram MM, Bae S, Locke JE, Reed RD, Lentine KL, Gupta G, Weir MR, Friedewald JJ, Verbesey J, Cooper M, Segev DL, Massie AB. Self-Reported Incident Hypertension and Long-Term Kidney Function in Living — View Citation

Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); — View Citation

Lee JH, Kim SC, Han DJ, Chang JW, Yang WS, Park SK, Lee SK, Park JS, Kim SB. Risk factors for MDRD-GFR of less than 60 mL/min per 1.73 m2 in former kidney donors. Nephrology (Carlton). 2007 Dec;12(6):600-6. doi: 10.1111/j.1440-1797.2007.00852.x. — View Citation

Lentine KL, Kasiske BL, Levey AS, Adams PL, Alberu J, Bakr MA, Gallon L, Garvey CA, Guleria S, Li PK, Segev DL, Taler SJ, Tanabe K, Wright L, Zeier MG, Cheung M, Garg AX. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors — View Citation

Lentine KL, Lam NN, Axelrod D, Schnitzler MA, Garg AX, Xiao H, Dzebisashvili N, Schold JD, Brennan DC, Randall H, King EA, Segev DL. Perioperative Complications After Living Kidney Donation: A National Study. Am J Transplant. 2016 Jun;16(6):1848-57. doi: — View Citation

Lentine KL, Lam NN, Segev DL. Risks of Living Kidney Donation: Current State of Knowledge on Outcomes Important to Donors. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):597-608. doi: 10.2215/CJN.11220918. Epub 2019 Mar 11. — View Citation

Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. — View Citation

Low PA, Opfer-Gehrking TL, McPhee BR, Fealey RD, Benarroch EE, Willner CL, Suarez GA, Proper CJ, Felten JA, Huck CA, et al. Prospective evaluation of clinical characteristics of orthostatic hypotension. Mayo Clin Proc. 1995 Jul;70(7):617-22. doi: 10.4065/ — View Citation

Mills KT, Chen J, Yang W, Appel LJ, Kusek JW, Alper A, Delafontaine P, Keane MG, Mohler E, Ojo A, Rahman M, Ricardo AC, Soliman EZ, Steigerwalt S, Townsend R, He J; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Sodium Excretion and the Ri — View Citation

Mjoen G, Hallan S, Hartmann A, Foss A, Midtvedt K, Oyen O, Reisaeter A, Pfeffer P, Jenssen T, Leivestad T, Line PD, Ovrehus M, Dale DO, Pihlstrom H, Holme I, Dekker FW, Holdaas H. Long-term risks for kidney donors. Kidney Int. 2014 Jul;86(1):162-7. doi: 1 — View Citation

Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for bloo — View Citation

Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approa — View Citation

Subramanian L, Kirk R, Cuttitta T, Bryant N, Fox K, McCall M, Perry E, Swartz J, Restovic Y, Jeter A, Bernardo A, Robinson B, Perl J, Pisoni R, Perlman RL. Remote Management for Peritoneal Dialysis: A Qualitative Study of Patient, Care Partner, and Clinic — View Citation

Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med. 1994 Aug 11;331(6):365-76. doi: 10.1056/NEJM199408113310606. No abstract available. — View Citation

Svetkey LP, Sacks FM, Obarzanek E, Vollmer WM, Appel LJ, Lin PH, Karanja NM, Harsha DW, Bray GA, Aickin M, Proschan MA, Windhauser MM, Swain JF, McCarron PB, Rhodes DG, Laws RL. The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-sodium): rational — View Citation

Tantisattamo E, Dafoe DC, Reddy UG, Ichii H, Rhee CM, Streja E, Landman J, Kalantar-Zadeh K. Current Management of Patients With Acquired Solitary Kidney. Kidney Int Rep. 2019 Jul 11;4(9):1205-1218. doi: 10.1016/j.ekir.2019.07.001. eCollection 2019 Sep. — View Citation

Yoon CY, Noh J, Lee J, Kee YK, Seo C, Lee M, Cha MU, Kim H, Park S, Yun HR, Jung SY, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. High and low sodium intakes are associated with incident chronic kidney disease in patients with normal renal function and hype — View Citation

Young A, Storsley L, Garg AX, Treleaven D, Nguan CY, Cuerden MS, Karpinski M. Health outcomes for living kidney donors with isolated medical abnormalities: a systematic review. Am J Transplant. 2008 Sep;8(9):1878-90. doi: 10.1111/j.1600-6143.2008.02339.x. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups	Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups, adjusting for patients' demographic and clinical differences (age, gender, BMI, and comorbidities) between the two treatment groups	4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Secondary	Hypertension	New-onset hypertension defined as systolic blood pressure >/= 130 or diastolic blood pressure >/=80 mmHg	4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Secondary	Worsening kidney function	Increased estimated glomerular filtration rate (eGFR) >/= 25 ml/min/1.73 m2 or increased serum creatinine >/= 0.3 mg/dL	4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Secondary	Worsening proteinuria	Increase in urinary albumin excretion rate (AER) =30 mg/day	4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Secondary	Proteinuria	New-onset urinary albumin excretion rate (AER) =30 mg/day	4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover