Appendix F

Presentation of Results—Evidence Tables

This appendix contains tables summarizing the studies reviewed by the committee organized by health outcome, type of study, and alphabetically by first author. Studies that reviewed multiple health outcomes are listed in more than one table. Some studies included in these tables were not included in the committee’s final review and assessment of the evidence for associations between dietary sodium intake and outcomes discussed in Chapter 4 due to inability to meet the inclusion criteria. As described in Chapter 2, the committee reviewed peer-reviewed original research studies (excluding case studies and case series), published in the English language and published between January 1, 2003, and December 18, 2012, including those conducted in all countries and with all sample sizes, populations, and follow-up periods. Studies were excluded if they included only intermediate outcomes; did not use a food frequency questionnaire, 24-hour recall, dietary diary, or urine analysis methods to estimate dietary sodium intake; did not calculate numerical sodium levels; or did not analyze the independent association between sodium and a health outcome. Studies that reviewed multiple health outcomes are included in more than one table.



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Appendix F Presentation of Results—Evidence Tables This appendix contains tables summarizing the studies reviewed by the committee organized by health outcome, type of study, and alphabeti- cally by first author. Studies that reviewed multiple health outcomes are listed in more than one table. Some studies included in these tables were not included in the committee’s final review and assessment of the evidence for associations between dietary sodium intake and outcomes discussed in Chapter 4 due to inability to meet the inclusion criteria. As described in Chapter 2, the committee reviewed peer-reviewed original research studies (excluding case studies and case series), published in the English language and published between January 1, 2003, and December 18, 2012, includ- ing those conducted in all countries and with all sample sizes, populations, and follow-up periods. Studies were excluded if they included only inter- mediate outcomes; did not use a food frequency questionnaire, 24-hour recall, dietary diary, or urine analysis methods to estimate dietary sodium intake; did not calculate numerical sodium levels; or did not analyze the independent association between sodium and a health outcome. Studies that reviewed multiple health outcomes are included in more than one table. 145

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146 SODIUM INTAKE IN POPULATIONS LIST OF TABLES • Table F-1 Evidence Tables: CVD/Stroke/Mortality Randomized Controlled Trials, 150 • Table F-2 Evidence Tables: CVD/Stroke/Mortality Cohort Studies, 152 • Table F-3 Evidence Tables: CVD/Stroke/Mortality Case-Control Studies, 174 • Table F-4 Evidence Tables: Congestive Heart Failure Randomized Controlled Trials, 176 • Table F-5 Evidence Tables: Congestive Heart Failure Cohort Stud- ies, 180 • Table F-6 Evidence Tables: Kidney Disease Cohort Studies, 182 • Table F-7 Evidence Tables: Diabetes Cohort Studies, 186 • Table F-8 Evidence Tables: Metabolic Syndrome and Diabetes Cross-Sectional Studies, 190 • Table F-9 Evidence Tables: Gastrointestinal Cancer Cohort Studies, 194 • Table F-10 Evidence Tables: Gastrointestinal Cancer Case-Control Studies, 204 REFERENCES Arakawa, K., Y. Matsushita, H. Matsuo, N. Ikeda, M. Iwashita, and K. Kuramoto. 2009. Examination of the efficiency of salt taste preference questionnaire in hypertensive patients—Results from post marketing surveillance of Olmetec (R) tablets and Calblock (R) tablets. Rinsho Iyaku 25:723-734. Arcand, J., J. Ivanov, A. Sasson, V. Floras, A. Al-Hesayen, E. R. Azevedo, S. Mak, J. P. Allard, and G. E. Newton. 2011. A high-sodium diet is associated with acute decompensated heart failure in ambulatory heart failure patients: A prospective follow-up study. Ameri- can Journal of Clinical Nutrition 93(2):332-337. Baune, B. T., Y. Aljeesh, and R. Bender. 2005. Factors of non-compliance with the therapeutic regimen among hypertensive men and women: A case-control study to investigate risk factors of stroke. European Journal of Epidemiology 20(5):411-419. Chang, H. Y., Y. W. Hu, C. S. Yue, Y. W. Wen, W. T. Yeh, L. S. Hsu, S. Y. Tsai, and W. H. Pan. 2006. Effect of potassium-enriched salt on cardiovascular mortality and medical expenses of elderly men. American Journal of Clinical Nutrition 83(6):1289-1296. Cohen, H. W., S. M. Hailpern, J. Fang, and M. H. Alderman. 2006. Sodium intake and mor- tality in the NHANES II follow-up study. American Journal of Medicine 119(3):275. e7-275.e14. Cohen, H. W., S. M. Hailpern, and M. H. Alderman. 2008. Sodium intake and mortality f ­ ollow-up in the Third National Health and Nutrition Examination Survey (NHANES III). Journal of General Internal Medicine 23(9):1297-1302. Cook, N. R., J. A. Cutler, E. Obarzanek, J. E. Buring, K. M. Rexrode, S. K. Kumanyika, L. J. Appel, and P. K. Whelton. 2007. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: Observational follow-up of the trials of hypertension prevention (TOHP). British Medical Journal 334(7599):885-888.

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APPENDIX F 147 Cook, N. R., E. Obarzanek, J. A. Cutler, J. E. Buring, K. M. Rexrode, S. K. Kumanyika, L. J. Appel, and P. K. Whelton. 2009. Joint effects of sodium and potassium intake on subsequent cardiovascular disease: The trials of hypertension prevention follow-up study. Archives of Internal Medicine 169(1):32-40. Costa, A. P. R., R. C. S. de Paula, G. F. Carvalho, J. P. Araújo, J. M. Andrade, O. L. R. de Almeida, E. C. de Faria, W. M. Freitas, O. R. Coelho, J. A. F. Ramires, J. C. Quinaglia e Silva, and A. C. Sposito. 2012. High sodium intake adversely affects oxidative-inflammatory ­ response, cardiac remodelling and mortality after myocardial infarction. Atherosclerosis 222(1):284-291. Daimon, M., H. Sato, S. Sasaki, S. Toriyama, M. Emi, M. Muramatsu, S. C. Hunt, P. N. Hopkins, S. Karasawa, K. Wada, Y. Jimbu, W. Kameda, S. Susa, T. Oizumi, A. Fukao, I. Kubota, S. Kawata, and T. Kato. 2008. Salt consumption-dependent association of the GNB3 gene polymorphism with type 2 DM. Biochemical & Biophysical Research Com- munications 374(3):576-580. Dong, J., Y. Li, Z. Yang, and J. Luo. 2010. Low dietary sodium intake increases the death risk in peritoneal dialysis. Clinical Journal of the American Society of Nephrology 5(2):240-247. Ekinci, E. I., S. Clarke, M. C. Thomas, J. L. Moran, K. Cheong, R. J. MacIsaac, and G. Jerums. 2011. Dietary salt intake and mortality in patients with type 2 diabetes. Diabetes Care 34(3):703-709. Gardener, H., T. Rundek, C. B. Wright, M. S. V. Elkind, and R. L. Sacco. 2012. Dietary sodium and risk of stroke in the Northern Manhattan Study. Stroke 43(5):1200-1205. Geleijnse, J. M., J. C. M. Witteman, T. Stijnen, M. W. Kloos, A. Hofman, and D. E. Grobbee. 2007. Sodium and potassium intake and risk of cardiovascular events and all-cause mortality: The Rotterdam Study. European Journal of Epidemiology 22(11):763-770. Heerspink, H. J. L., F. A. Holtkamp, H. H. Parving, G. J. Navis, J. B. Lewis, E. Ritz, P. A. De Graeff, and D. De Zeeuw. 2012. Moderation of dietary sodium potentiates the renal and cardiovascular protective effects of angiotensin receptor blockers. Kidney Interna- tional 82(3):330-337. Hu, G., P. Jousilahti, M. Peltonen, J. Lindstrom, and J. Tuomilehto. 2005. Urinary sodium and potassium excretion and the risk of type 2 diabetes: A prospective study in Finland. Diabetologia 48(8):1477-1483. Jafar, T. H. 2006. Blood pressure, diabetes, and increased dietary salt associated with stroke— results from a community-based study in Pakistan. Journal of Human Hypertension 20(1):83-85. Kono, Y., S. Yamada, K. Kamisaka, A. Araki, Y. Fujioka, K. Yasui, Y. Hasegawa, and Y. Koike. 2011. Recurrence risk after noncardioembolic mild ischemic stroke in a Japanese population. Cerebrovascular Diseases 31(4):365-372. Larsson, S. C., M. J. Virtanen, M. Mars, S. Männistö, P. Pietinen, D. Albanes, and J. Virtamo. 2008. Magnesium, calcium, potassium, and sodium intakes and risk of stroke in male smokers. Archives of Internal Medicine 168(5):459-465. Lazarević, K., A. Nagorni, D. Bogdanović, N. Rančić, L. Stošić, and S. Milutinović. 2011. Di- etary micronutrients and gastric cancer: Hospital based study. Central European Journal of Medicine 6(6):783-787. Lee, S. A., D. Kang, K. N. Shim, J. W. Choe, W. S. Hong, and H. Choi. 2003. Effect of diet and Helicobacter pylori infection to the risk of early gastric cancer. Journal of Epidemi- ology 13(3):162-168. Lennie, T. A., E. K. Song, J. R. Wu, M. L. Chung, S. B. Dunbar, S. J. Pressler, and D. K. Moser. 2011. Three gram sodium intake is associated with longer event-free survival only in patients with advanced heart failure. Journal of Cardiac Failure 17(4):325-330.

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148 SODIUM INTAKE IN POPULATIONS McCausland, F. R., S. S. Waikar, and S. M. Brunelli. 2012. Increased dietary sodium is in- dependently associated with greater mortality among prevalent hemodialysis patients. Kidney International 82(2):204-211. Murata, A., Y. Fujino, T. M. Pham, T. Kubo, T. Mizoue, N. Tokui, S. Matsuda, and T. Yoshimura. 2010. Prospective cohort study evaluating the relationship between salted food intake and gastrointestinal tract cancer mortality in Japan. Asia Pacific Journal of Clinical Nutrition 19(4):564-571. Nagata, C., N. Takatsuka, N. Shimizu, and H. Shimizu. 2004. Sodium intake and risk of death from stroke in Japanese men and women. Stroke 35(7):1543-1547. O’Donnell, M. J., S. Yusuf, A. Mente, P. Gao, J. F. Mann, K. Teo, M. McQueen, P. Sleight, A. M. Sharma, A. Dans, J. Probstfield, and R. E. Schmieder. 2011. Urinary sodium and potassium excretion and risk of cardiovascular events. Journal of the American Medical Association 306(20):2229-2238. Parrinello, G., P. Di Pasquale, G. Licata, D. Torres, M. Giammanco, S. Fasullo, M. Mezzero, and S. Paterna. 2009. Long-term effects of dietary sodium intake on cytokines and neu- rohormonal activation in patients with recently compensated congestive heart failure. Journal of Cardiac Failure 15(10):864-873. Paterna, S., P. Gaspare, S. Fasullo, F. M. Sarullo, and P. Di Pasquale. 2008. Normal-sodium diet compared with low-sodium diet in compensated congestive heart failure: Is sodium an old enemy or a new friend? Clinical Science 114(3):221-230. Paterna, S., G. Parrinello, S. Cannizzaro, S. Fasullo, D. Torres, F. M. Sarullo, and P. Di Pasquale. 2009. Medium term effects of different dosage of diuretic, sodium, and fluid administra- tion on neurohormonal and clinical outcome in patients with recently compensated heart failure. American Journal of Cardiology 103(1):93-102. Paterna, S., S. Fasullo, G. Parrinello, S. Cannizzaro, I. Basile, G. Vitrano, G. Terrazzino, G. Maringhini, F. Ganci, S. Scalzo, F. M. Sarullo, G. Cice, and P. Di Pasquale. 2011. Short- term effects of hypertonic saline solution in acute heart failure and long-term effects of a moderate sodium restriction in patients with compensated heart failure with New York Heart Association class III (class C) (SMAC-HF study). American Journal of the Medical Sciences 342(1):27-37. Peleteiro, B., C. Lopes, C. Figueiredo, and N. Lunet. 2011. Salt intake and gastric cancer risk according to Helicobacter pylori infection, smoking, tumour site and histological type. British Journal of Cancer 104(1):198-207. Pelucchi, C., I. Tramacere, P. Bertuccio, A. Tavani, E. Negri, and C. La Vecchia. 2009. Dietary intake of selected micronutrients and gastric cancer risk: An Italian case-control study. Annals of Oncology 20(1):160-165. Rodrigues, S. L., M. P. Baldo, R. de Sa Cunha, R. V. Andreao, M. Del Carmen Bisi Molina, C. P. Goncalves, E. M. Dantas, and J. G. Mill. 2009. Salt excretion in normotensive in- dividuals with metabolic syndrome: A population-based study. Hypertension Research— Clinical & Experimental 32(10):906-910. Roy, M. S., and M. N. Janal. 2010. High caloric and sodium intakes as risk factors for progres- sion of retinopathy in type 1 diabetes mellitus. Archives of Ophthalmology 128(1):33-39. Shikata, K., Y. Kiyohara, M. Kubo, K. Yonemoto, T. Ninomiya, T. Shirota, Y. Tanizaki, Y. Doi, K. Tanaka, Y. Oishi, T. Matsumoto, and M. Iida. 2006. A prospective study of dietary salt intake and gastric cancer incidence in a defined Japanese population: The Hisayama study. International Journal of Cancer 119(1):196-201. Sjödahl, K., C. Jia, L. Vatten, T. Nilsen, K. Hveem, and J. Lagergren. 2008. Salt and gastric adenocarcinoma: A population-based cohort study in Norway. Cancer Epidemiology Biomarkers and Prevention 17(8):1997-2001.

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APPENDIX F 149 Stolarz-Skrzypek, K., T. Kuznetsova, L. Thijs, V. Tikhonoff, J. Seidlerová, T. Richart, Y. Jin, A. Olszanecka, S. Malyutina, E. Casiglia, J. Filipovský, K. Kawecka-Jaszcz, Y. Nikitin, and J. A. Staessen. 2011. Fatal and nonfatal outcomes, incidence of hypertension, and blood pressure changes in relation to urinary sodium excretion. Journal of the American Medical Association 305(17):1777-1785. Strumylaite, L., J. Zickute, J. Dudzevicius, and L. Dregval. 2006. Salt-preserved foods and risk of gastric cancer. Medicina 42(2):164-170. Takachi, R., M. Inoue, T. Shimazu, S. Sasazuki, J. Ishihara, N. Sawada, T. Yamaji, M. Iwasaki, H. Iso, Y. Tsubono, and S. Tsugane. 2010. Consumption of sodium and salted foods in relation to cancer and cardiovascular disease: The Japan Public Health Center-based prospective study. American Journal of Clinical Nutrition 91(2):456-464. Teramoto, T., R. Kawamori, S. Miyazaki, and S. Teramukai. 2011. Sodium intake in men and potassium intake in women determine the prevalence of metabolic syndrome in Japanese hypertensive patients: OMEGA Study. Hypertension Research 34(8):957-962. Thomas, M. C., J. Moran, C. Forsblom, V. Harjutsalo, L. Thorn, A. Ahola, J. Wadén, N. Tolonen, M. Saraheimo, D. Gordin, and P. H. Groop. 2011. The association between dietary sodium intake, ESRD, and all-cause mortality in patients with type 1 diabetes. Diabetes Care 34(4):861-866. Tikellis, C., R. J. Pickering, D. Tsorotes, V. Harjutsalo, L. Thorn, A. Ahola, J. Waden, N. Tolonen, M. Saraheimo, D. Gordin, C. Forsblom, P. H. Groop, M. E. Cooper, J. Moran, and M. C. Thomas. 2013. Association of dietary sodium intake with atherogenesis in experimental diabetes and with cardiovascular disease in patients with type 1 diabetes. Clinical Science 124(10):617-626. Tsugane, S., S. Sasazuki, M. Kobayashi, and S. Sasaki. 2004. Salt and salted food intake and subsequent risk of gastric cancer among middle-aged Japanese men and women. British Journal of Cancer 90(1):128-134. Umesawa, M., H. Iso, C. Date, A. Yamamoto, H. Toyoshima, Y. Watanabe, S. Kikuchi, A. Koizumi, T. Kondo, Y. Inaba, N. Tanabe, and A. Tamakoshi. 2008. Relations between dietary sodium and potassium intakes and mortality from cardiovascular disease: The Japan Collaborative Cohort study for evaluation of cancer risks. American Journal of Clinical Nutrition 88(1):195-202. van den Brandt, P. A., A. A. M. Botterweck, and R. A. Goldbohm. 2003. Salt intake, cured meat consumption, refrigerator use and stomach cancer incidence: A prospective cohort study (Netherlands). Cancer Causes and Control 14(5):427-438. Yang, Q., T. Liu, E. V. Kuklina, W. D. Flanders, Y. Hong, C. Gillespie, M. H. Chang, M. Gwinn, N. Dowling, M. J. Khoury, and F. B. Hu. 2011. Sodium and potassium intake and mortality among US adults: Prospective data from the Third National Health and Nutrition Examination Survey. Archives of Internal Medicine 171(13):1183-1191. Zhang, Z., and X. Zhang. 2011. Salt taste preference, sodium intake and gastric cancer in China. Asian Pacific Journal of Cancer Prevention 12(5):1207-1210.

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150 SODIUM INTAKE IN POPULATIONS TABLE F-1 Evidence Tables: CVD/Stroke/Mortality Randomized Controlled Trials Population Intervention/ Citation Studied Study Design Control Sample Size Chang et al., Five kitchens RCT Intervention Intervention 2006 at a veterans K-enriched salt 768 (mean age: retirement home, (49 percent 74.8±7.1 y) >40 y sodium chloride, 49 percent Control potassium 1,213 (mean age: chloride) 74.9±6.7 y) Control Regular salt NOTES FOR TABLES F-1 THROUGH F-10 *Indicates significance. Sodium intake presented as mmol was converted to mg using 23 mg/mmol. ACE, angiotensin-converting enzyme; ACM, all-cause mortality; ADHF, acute decompensated heart failure; amt, amount; ARB, angiotension recep- tor blockers; ARR, absolute risk reduction; BMI, body mass index; BP, blood pressure; Ca, calcium; CHD, coronary heart disease; CHF, congestive heart failure; CI, confidence interval; CKD, chronic kidney disease; CVD, cardiovascular disease; d, day; dl, deciliter; DM, diabetes mellitus; ESRD, end-stage renal disease; FFQ, food frequency questionnaire; g, grams; h, hour; HDL, high-density-lipoprotein cholesterol; HR, hazard ratio; HSS, hypertonic saline solution; IDNT, Irbesartan Diabetic Nephropathy Trial; IHD, ischemic heart disease; IS, ischemic stroke; K, potassium; Kt/V, mea- surement of urea removal; L, liter; LDL, low-density-lipoprotein cholesterol; LVEF, left ventricular ejection fraction; mg, milligrams; MI, myocardial

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APPENDIX F 151 Sodium Exposure (method and Follow-up Health level) Co-intervention Blinding Period Outcome Results Calculated from N/A Single blind 2.6 y ACM Use of number of meals (participants) (length of K-enriched served and intervention CVD salt associated amount of salt and mean mortality with significant used per day follow-up) reduction in CVD mortality; Intervention however, may 3,800 mg be primarily due to increased K Control intake 5,200 mg Intervention vs. Urine electrolyte Control data available for ACM HR=0.90, about 25% of the CI: 0.79, 1.06 subjects CVD mortality *Intervention: HR=0.59, CI: 0.37, 0.95 infarction; ml, milliliter; mm HG, millimeters mercury; mo, month; Na, sodium; N/A, not applicable; NCI, National Cancer Institute; NHANES, National Health and Nutrition Examination Survey; NS, not significant; NYHA, New York Heart Association; ONTARGET, ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial; OR, odds ratio; Q, quartile/quintile; RAAS, rennin-angiotensin-aldosterone system; RCT, randomized controlled trial; RENAAL, Reduction of Endpoints in NIDDM with the Angiotensiin II Antagonist Losartan Study; RR, relative risk; sat. fat, saturated fat; SD, standard deviation; T, tertile; TOHP, Tri- als of Hypertension Prevention; TRANSCEND, Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease; UK, urinary potassium; UNa, urinary sodium; USDA, U.S. Department of Agriculture; vs., versus; wk, week; y, year.

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152 SODIUM INTAKE IN POPULATIONS TABLE F-2  Evidence Tables: CVD/Stroke/Mortality Cohort Studies Sodium Exposure Citation Population Studied Study Design Sample Size (method and level) Cohen NHANES II, 30-74 y, Prospective 7,154 24-h dietary recall of Na et al., 2006 without a history of cohort intake at baseline CVD events Na intake levels ≥2,300 mg/d <2,300 mg/d Cohen NHANES III, ≥30 y, Prospective 8,699 24-h dietary recall of Na et al., 2008 without a history of cohort intake at baseline CVD events Na intake quartiles (intake level): Q1: <2,060 mg/d (1,501 mg/d) Q2: 2,060-2,921 mg/d (2,483 mg/d) Q3: 2,922-4,047 mg/d (3,441 mg/d) Q4: 4,048-9,946 mg/d (5,497 mg/d) Cook et al., Subset of 2,415 Prospective TOHP I TOHP I 2007 participants from cohort Intervention: 24-h urine collection 2 RCTs: 327 (232 men; at baseline, 6, 12, and 95 women) 18 mo. TOHP (United States) 30-54 y with diastolic TOHP I Net Na reduction at BP 80-89 mmHg Control: 417 18 mo.=1,012 mg/24 h (prehypertensives) (299 men; 118 (3,577 to 2,565 mg/d) women) TOHP II (United States) TOHP II 30-54 y with diastolic TOHP II 24-h urine collection at BP 83-89 mmHg and Intervention: baseline, 18, and 36 mo. weighing 110-165% of 1,191 (784 their desirable weight men; 407 Net Na reduction at 36 (prehypertensives) women) mo.=759 mg/24 h (4,225 to 3,466 mg/d) TOHP II Control: 1,191 (782 men; 409 women)

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APPENDIX F 153 Follow-up Confounders Period Health Outcome Adjusted for Results 13.7 y ACM Age, sex, race, smoking, Lower Na intake associated with alcohol use, systolic increased risk of ACM and CVD CVD mortality BP, antihypertensive mortality treatment, BMI, CHD mortality education OCR for page 145
154 SODIUM INTAKE IN POPULATIONS TABLE F-2  Continued Sodium Exposure Citation Population Studied Study Design Sample Size (method and level) Cook et al., Subset of 2,275 Prospective 2,275 TOHP I 2009 participants from cohort 24-h urine collection 2 RCTs: at baseline, 6, 12, and TOHP (United States) 18 mo. 30-54 y with diastolic BP 80-89 mmHg TOHP II (prehypertensives) 24-h urine collection at baseline, 18, and 36 mo. TOHP II (United States) 30-54 y with diastolic Median excretion BP 83-89 mmHg and Overall: 3,634 mg/24 h weighing 110-165% of (interquartile range: their desirable weight 2,921-4,462 mg/24 h) (prehypertensives) Men: 3,933 mg/24 h Women: 3,082 mg/24 h Na excretion quartiles (not provided) Costa Brasilia Heart Study Prospective 372 62-item FFQ et al., 2012 subjects diagnosed with cohort MI Na intake quantified using Brazilian Table of Food Composition, version 2 Na intake levels ≥1,200 mg/d=high; <1,200 mg/ d=low Dong et al., Chinese patients Retrospective 305 3-d dietary records 2010 receiving peritoneal cohort completed by patients dialysis at single clinic, (129 men; and checked by dietitian mean age=59.4±14.2 y 176 women) using food models Na calculated using computer software Na intake tertiles (average intake=1,820 mg/d; range=760-5,530 mg/d)

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APPENDIX F 155 Follow-up Confounders Period Health Outcome Adjusted for Results 10-15 y CVD events Age, sex, race/ethnicity, Non-significant, relationship clinic, treatment between UNa excretion and risk assignment, education of CVD status, baseline weight, alcohol use, smoking, Q1: RR=1.0 exercise, family history Q2: RR=0.99, CI: 0.62, 1.58 of CVD, changes in Q3: RR=1.16, CI: 0.73, 1.84 weight, smoking, Q4: RR=1.20, CI: 0.73, 1.97 exercise p for trend=0.38 Adjusted for potassium excretion: *HR=1.42 (0.99-2.04) per 100 mmol/24 hr sodium, p=0.05 4y ACM Age, sex, hypertension, Risk of death was higher among diabetes, sedentarity, individuals with Na intake >1,200 BMI mg/d *Exp(B)=2.857, CI: 1.501, 5.437, p=0.01 31.4±13.7 mo. ACM Age, sex, BMI, history Lower Na intake associated with of DM or CVD, increased risk of ACM and CVD CVD mortality baseline total Kt/V, total mortality creatinine clearance, mean arterial pressure, ACM serum albumin, *HR=0.44, CI: 0.20, 0.95, p=0.04 hemoglobin, Ca × phosphate, LDL CVD mortality *HR=0.11, CI: 0.03, 0.48, p=0.003 continued

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200 SODIUM INTAKE IN POPULATIONS TABLE F-9  Continued Study Sample Sodium Exposure Citation Population Studied Design Size (method and level) Tsugane Japanese, 40-59 Population- 39,065 Self-administered et al., y, without a self- based 27-item FFQ assessing 2004 reported serious prospective (18,684 weekly intake illness (cancer, cohort men; cerebrovascular 20,381 Na intake calculated disease, MI, chronic women) using the Standardized liver disease) Tables of Food Composition (Science Individuals were from and Technology 14 administrative Agency, 1982) districts supervised by 4 regional public Individuals with health centers extreme energy intakes were excluded (upper and lower 2.5%) Validated with 28-day dietary record Na intake quintiles by median: Q1: 2,900 mg/day Q2: 4,800 mg/day Q3: 6,100 mg/day Q4: 7,500 mg/day Q5: 9,900 mg/day

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APPENDIX F 201 Follow-up Health Confounders Period Outcome Adjusted for Results 12 y Gastric cancer Age, smoking, fruit High salted foods were and non-green-yellow strongly associated with vegetable gastric cancer in men intake Men Q1: RR=1.00 Q2: RR=1.74, CI: 1.14, 2.66 Q3: RR=1.96, CI: 1.30, 2.97 Q4: RR=2.30, CI: 1.53, 3.46 Q5: RR=2.23, CI: 1.48, 3.35 *p for trend<0.001 Women Q1: RR=1.00 Q2: RR=0.86, CI: 0.47, 1.56 Q3: RR=0.96, CI: 0.54, 1.72 Q4: RR=0.58, CI: 0.30, 1.12 Q5: RR=1.32, CI: 0.76, 2.28 p for trend=0.48 Further stratification by study location diminished the association continued

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202 SODIUM INTAKE IN POPULATIONS TABLE F-9  Continued Study Sample Sodium Exposure Citation Population Studied Design Size (method and level) van den Dutch, 55-69 y, Prospective 120,852 Semiquantitative 150- Brandt excluding those with cohort item FFQ (dietary et al., stomach cancer at (58,279 salt intake, salty food 2003 baseline men; intake, added salt) 62,573 women) Dietary Na calculated using computerized Dutch food composition table and validated against 9 dietary records Na intake adjusted for energy intake Na intake quintiles by median: Q1: 1,640 mg/d Q2: 2,040 mg/d Q3: 2,280 mg/d Q4: 2,600 mg/d Q5: 3,240 mg/d

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APPENDIX F 203 Follow-up Health Confounders Period Outcome Adjusted for Results 6.3 y Stomach Energy, age, sex, No relationship between cancer education level, self- energy-adjusted salt intake reported stomach quintiles and stomach disorders, family history cancer of stomach cancer, smoking status Q1 vs. Q5 Positive, nonsignificant associations were found for bacon (RR=1.33; CI 1.03, 1.71) and other sliced cold meats (RR=1.29; CI: 0.96, 1.72, p for trend=0.07)

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204 SODIUM INTAKE IN POPULATIONS TABLE F-10 Evidence Tables: Gastrointestinal Cancer Case-Control Studies Sample Size Citation Population studied Study Design (case/control) Lazarević et Cases: Serbian, 45-85 y, Hospital-based 102 cases al., 2011 diagnosed with gastric case-control 204 controls adenocarcinoma Controls: Serbians matched by age, sex, and residence Lee et al., Cases: Korean men and women Hospital-based 69 cases 2003 diagnosed with gastric cancer and case-control 199 controls without H. pylori infection Controls: Korean men and women Peleteiro et Cases: Portuguese, diagnosed with Hospital-based 422 cases al., 2011 gastric cancer case-control 649 controls Controls: Portuguese, 18-92 y

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APPENDIX F 205 Sodium Exposure Confounders (method and level) Health Outcome Adjusted for Results 98-item FFQ Gastric cancer Association of Na intake with gastric National food cancer in men: composition tables and USDA food T2 vs. T1 composition tables *OR=4.66, CI: 0.28, 19.96, p=0.000 Na intake tertiles (no ranges or T3 vs. T1 median provided) *OR=6.22, CI: 1.99, 7.86, p=0.000 Person-to- Gastric cancer Age, sex, family Increase in early person interview history, duration gastric cancer risk conducted using of education, positively and semiquantitative smoking, drinking, significantly associated 161-item FFQ H. pylori infection with increased intake of salt-fermented fish (*HR=2.4, CI: 1.0, 5.7) and kimchi No Na intake (*HR=1.9, CI: 1.3, levels provided; 2.8) frequency of consumption of various foods Semiquantitative Gastric cancer Age, sex, Risk of gastric cancer 82 item FFQ T1: education, associated with highest <3,067.5 mg/d smoking, H. pylori salt exposure (T3 vs. T2: 3,067.5- infection, total T1): 3,960.1 mg/d energy intake *OR=2.01, CI: 1.16, T3: >,3960.1 mg/d 3.46 continued

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206 SODIUM INTAKE IN POPULATIONS TABLE F-10 Continued Sample Size Citation Population studied Study Design (case/control) Pelucchi et Cases: Italian men and women, Hospital-based 230 cases al., 2009 22-80 y, with confirmed stomach case-control 547 controls cancer Controls: Italian men and women, 22-80 y, frequency matched by age and sex Strumylaite Cases: Lithuanian with newly Hospital-based 379 cases et al., 2006 diagnosed gastric cancer, 22-86 y case-control 1,137 controls Controls: Lithuanian individually matched by gender and age ±5 y

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APPENDIX F 207 Sodium Exposure Confounders (method and level) Health Outcome Adjusted for Results 78-item FFQ Gastric cancer Education, period Gastric cancer was grouped into 6 of interview, BMI, associated with Na sections (milk/hot smoking, family intake compared to beverages, bread/ history of stomach Q1: cereal dishes, cancer in first- Q2: OR=2.22, CI: meat/main dishes, degree relatives, 1.27, 3.88 vegetables, fruit, total energy intake Q3: OR=2.56, CI: sweets/ desserts/soft 1.41, 4.63 drinks) Q4: OR=2.46, CI: 1.22, 4.95 Na intake *p for trend=0.02 computed using an Italian food composition database (with other sources when needed) Na intake quartiles (not provided) Self-administered Gastric cancer Smoking, alcohol Increased risk structured consumption, of gastric cancer questionnaire family history of associated with: about dietary cancer, education habits (56 diet level, residence, Use of additional salt: items) based other dietary *OR=2.98, CI: on the Aichi habits (e.g., speed 2.15, 4.15, p for Cancer Center of eating), other trend<0.001 Questionnaire dietary habits, No Na intake smoking, alcohol Liking salty foods: levels provided consumption, *OR=3.88 CI: family history of 1.98, 7.60, p for cancer, education trend<0.001 level, residence Putting additional salt on prepared meal: *OR=2.98 CI: 2.15, 4.15, p for trend<0.001 continued

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208 SODIUM INTAKE IN POPULATIONS TABLE F-10 Continued Sample Size Citation Population studied Study Design (case/control) Zhang and Cases: Japanese men and women Population-based 235 cases Zhang, 2011 diagnosed with gastric cancer, case-control 410 controls 40-75 y Controls: Japanese men and women, 35-77 y

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APPENDIX F 209 Sodium Exposure Confounders (method and level) Health Outcome Adjusted for Results 98-item FFQ Gastric cancer Age, sex, education Na intake was level, smoking, associated with an Daily Na intake alcohol intake, H. increased risk of calculated by pylori infection gastric cancer: national food T1: OR=1.00 composition tables T2: OR=1.95, CI: and the USDA food 1.23, 3.03, p=0.012 composition tables T3: OR=3.78, CI: 1.74, 5.44, p=0.12 Na intake tertiles T1: <3,000 mg/d T2: 3,000-5,000 mg/d T3: >5,000 mg/d

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