Family-Based Randomized Trial to Detect Effects on Blood Pressure of a Salt Substitute Containing Potassium and Calcium in Hypertensive Adolescents

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1 nature publishing group Family-Based Randomized Trial to Detect Effects on Blood Pressure of a Salt Substitute Containing Potassium and Calcium in Hypertensive Adolescents Jianjun Mu 1, Zhiquan Liu 1, Fuqiang Liu 1, Xianglin Xu 1, Yimu Liang 1 and Danjun Zhu 1 BACKGROUND Potassium and calcium are important in blood pressure (BP) regulation. The aim of this study was to test the effects on BP of adding potassium and calcium to dietary salt. METHODS A total of 35 adolescents selected with high BP (systolic BP () 9th percentile by age and sex) along with 978 family members. The adolescents were randomized into three groups by coin toss, and their families (3 total) were also allocated to the three groups: one in which 1 mmol of potassium and 1 mmol of calcium were added to the cooking salt, one encouraged to follow a salt-restricted diet, and a control group. In the salt-restricted group, salt intake was decreased gradually through health-behavior education to reach the goal of 5 1 mmol per person per day at years. No intervention took place in for the control group. Salt sensitivity was determined by a volume expansion and contraction protocol at the beginning of the study. The three groups were followed up every months for years. RESULTS At years, systolic and diastolic blood pressure (/) had decreased by 5.9/.8 mm Hg (.7/3.%) in the added-potassium-andcalcium group and by 5.8/1. mm Hg (.8/1.%) in the salt-restricted group; the values rose in the control group by 1.3/.3 mm Hg (1.1/1.8%). There was no difference between the added-potassiumand-calcium group and the restricted-salt group (P =.), but both differed significantly from the controls (P <.5). Similar changes in BP were found in family members. Subgroup analysis showed that the BP in salt-sensitive (SS) subjects decreased more than in the non-saltsensitive (NSS) group (P <.5). CONCLUSION A salt substitute containing potassium and calcium was as effective as sodium restriction in reducing BP in hypertensive adolescents and their families in a that rural Chinese community. Am J Hypertens 9; : American Journal of Hypertension, Ltd. The prevalence of hypertension in China has risen rapidly during the past 3 years. A survey indicated that nearly 18% of Chinese adults (aged 15 years) had hypertension, corresponding to 177 million people in mainland China. 1 Salt may play an important role in the development of hypertension, and guidelines for prevention and treatment of hypertension agree that salt restriction is an effective intervention for preventing hypertension. However, poor compliance is a stumbling block in primary care of hypertension in China. Epidemiological and clinical studies have shown that potassium intake has an important role in blood pressure (BP) control in the general population and in people with high BP. 5, A meta-analysis of 33 clinical trials, involving 1,5 hypertensive and 1,5 normotensive subjects, indicated that oral potassium supplementation can significantly lower BP, either systolic () or diastolic BP (). 7 It also indicated an 1 Department of Cardiology, First Affiliated Hospital of Medical School of Xi an Jiaotong University, Xi an, People s Republic of China. Correspondence: J.J. Mu (mujjun@13.com) Received May 9; first decision 1 June 9; accepted 1 June 9; advance online publication August 9. doi:1.138/ajh American Journal of Hypertension, Ltd. association between calcium intake and BP, but the findings are inconsistent and may have been confounded in some of the calcium-supplementation trials. 8,9 Recently, Mierlo performed a meta-analysis of randomized control trial that showed that the effects of calcium supplementation on BP tended to be more pronounced in populations with a habitually low calcium intake and suggested that an adequate intake of calcium be recommended for the prevention of hypertension. 1 The dietary pattern of Chinese people, especially in the rural areas of northern China, is characterized by high sodium intake and low potassium and calcium intake. Our previous survey demonstrated that people there consume 3 mmol sodium/day but only 35 mmol potassium/day and 1 mmol calcium/day on average; the K/Na ratio was nearly.15, which is far lower than the ratio of. recommended by the National High Blood Pressure Education Program. 11 We presume that adding potassium and calcium to cooking salt, elevating the ratios of K and Ca to Na, would be a feasible hypertension-prevention approach. Our previous study demonstrated that moderate increases of potassium and calcium intake in schoolchildren could delay or lessen the rise in BP with age. 1 To observe the effects on BP of adding potassium AMERICAN JOURNAL OF HYPERTENSION VOLUME NUMBER september 9 93 Downloaded from

2 Salt Substitute and Blood Pressure and calcium to dietary salt on BP, a family-based intervention program was carried out in adolescents with high BP and their family members who lived together. Methods The study was a randomized, single-blind, placebo-controlled trial in three rural villages of Hanzhong, in northwest China. The trial was approved by the ethics committees of Xi an Jiaotong University, China. All participants provided informed consent. Study population. A group of 35 adolescents with high BP defined as 9th percentile by age and sex, screened from,3 subjects who have been followed up for 1 years, were enrolled, as well as the families (3 total) with whom they live, for a total of 978 family members. The participants were required to have no contraindication to the supplementation of potassium and calcium, such as the use of a potassiumsparing medication or significant renal impairment. A blood test was done at registration and at randomization to check serum creatinine and potassium levels. Any individual with abnormal blood tests confirmed by the responsible physician was excluded. Of the group, only one was excluded for renalvascular hypertension. Study protocol. After randomization by coin toss, particpants were allocated to three groups. For the added-potassium-andcalcium group, we supplied the families with salt to which potassium chloride and calcium chloride had been added, according to the daily salt consumption of each family, such that each person would consume approximately 1 mmol of potassium and 1 mmol of calcium extra per day. In the salt-restricted group, salt intake gradually decreased through health-behavior education; the goal was 5 1 mmol per person per day at the end of years. No interventions were taken with the controls. Salt was supplied freely to all the groups. Our researchers visited to each family 15 kitchen to assess the amount of salt consumed every month. Participants were asked to eat dinners all their dinners at home throughout the study duration. Participants were followed up every months. At baseline and at follow-up visits, BP, heart rate, weight, height, and overnight 8-h urinary potassium and sodium excretion were measured. An interview about the past 3 days food consumption and a questionnaire assessing knowledge of high BP were also completed at baseline and at follow-up. BP measurements. BP recordings were taken in a sitting position, with the right arm bared, supported, and positioned at heart level, after at least a 5-min rest in a bright and quiet a room with the temperature kept at 18 C, using a mercury sphygmomanometer with a suitable cuff size. After selection of the appropriately sized cuff, to completely encircle the arm without overlap, the cuff was applied snugly around the arm with the lower edge above the antecubital space and was inflated to about 3 mm Hg above the points at which the radial pulse disappeared. The cuff pressure was then released at a rate of about 3 mm Hg/s while auscultation was performed over the brachial artery. The first appearance of Korotkoff sounds was taken as the systolic pressure, and the fifth phase as diastolic pressure. Three measurements were usually performed for calculating the mean values, with 3 s between the measurements. Heart beats were counted for 3 s in the sitting position after a rest of 5 min. Height and weight were measured while wearing shorts or clothes light weight without shoes. Experimental determination. An antiseptic container was distributed to every participant for 8-h overnight specimen collection. Concentrations of potassium and sodium were measured by flame spectrophotometer. Salt-sensitivity measurements. Salt sensitivity was measured at the beginning of the intervention by a volume expansion and volume contraction protocol as described elsewhere. 13 Statistical analyses. The data were shown as mean values ± s.d. The increase in value of BP (end point BP baseline BP) and the BP increase range ((end point BP baseline BP)/baseline BP 1) were calculated. We applied general linear models with family codes as a random factor and treatment as a fix factor. The Student Newman Keuls t-test was used for a post hoc test. All calculations were performed with SPSS for Windows, version 13 (SPSS, Chicago, IL). Results A total of 35 adolescents with high BP were registered for the study. Of those, only 35 (93%) were randomized. The total of related family members was 978 persons. The main reason for participants failing to randomize was inable to have their dinners at home all or nearly all the time throughout the study duration. Table 1 lists the characteristics of the three groups. The follow-up rate was 9.% in adolescents and 85.7% in family members at the final follow-up. Of the adolescents, 3 people were withdrawn from the study: 18 moved away, joined the army, 8 went to remote places to work, and withdraw for other reasons. Dynamic changes in dietary sodium and potassium Table and Figure 1 show the dynamic changes in dietary sodium and potassium seen at the follow-ups. We can clearly see that the dietary salt in the salt-restricted group was gradually decreased and had reached 5 mmol/day at the end. It was even lower than that in the added-potassium-and-calcium group (P <.5). No differences in potassium intake were found at follow-up among the three groups (P >.5). Dynamic changes in overnight 8-h urinary electrolytes In the salt-restricted group, overnight 8-h sodium excretion gradually decreased and reached the lowest at the end. It was much lower level than that in the added-potassium-and-calcium group and in the control group (P <.5). Overnight potassium excretion in the added-potassium-and-calcium was increased 9 september 9 VOLUME NUMBER 9 AMERICAN JOURNAL OF HYPERTENSION Downloaded from

3 Salt Substitute and Blood Pressure Table 1 Characteristics of the study groups Parameter Number of adolescents with HBP Added-Kand- Ca group Restrictedsalt group Control group Mean age (years).3 ± 3.1. ± ± 3.9 Sex (male/female) 55/5 58/5 /5 BMI (kg/m ) 3. ±. 3. ± ±.1 Systolic BP (mm Hg) 13.8 ± ± ± 1.1 Diastolic BP (mm Hg) 75. ± ± ± 11.8 Heart rate (beats/min) 79. ± ± ± 8. Sodium intake (mmol) 1 ± ± ± 9 Potassium intake (mmol) 37.1 ± ± ± 13.7 Calcium intake (mmol).8 ± ±.9.8 ± 3. Overnight 8-h UNa (mmol) 1.8 ± ± ± 7. Overnight 8-h UK (mmol).8 ± ±..7 ±. Number of households Total number of family members BMI, body mass index; HBP, high blood pressure; UK, urinary potassium; UNa, urinary sodium.. Table Dynamic changes of dietary sodium and potassium intake during the follow-ups Group Baseline Months 1 Year Years Sodium intake (mmol/day) 1 ± 59 1 ± 5 13 ± ± Potassium intake (mmol/day) a 3 ± 1 ± ± ± 15 Salt-restricted group Sodium intake (mmol/day) 11 ± 5 11 ± 1 ± 5 87 ± 1 Potassium intake (mmol/day) 37 ± 13 8 ± 1 3 ± ± 1 Sodium intake (mmol/day) 137 ± 9 17 ± ± ± Potassium intake (mmol/day) 3 ± 13 7 ± 15 3 ± 1 3 ± 18 a Excluding potassium added to salt. P <.5, compared with the salt-restricted group. P <.5, compared with the baseline. throughout and was higher than that in the salt- restricted group and the control group, (P <.5) (Figures and 3). Dynamic changes in BP After the -year intervention, had decreased by 5.9 mm Hg (.7%) and DPB by.8 mm Hg (3.%) in the added- potassiumand-calcium group. In the salt-restricted group, had fallen by 5.8 mm Hg (.8%) and by 1. mm Hg (1.%). In the control group, however, had risen by 1.3 mm Hg (1.1%) and by.3 mm Hg (1.8%). There was no difference between the added-potassium-and-calcium group and the restricted salt group (P =.) (Figure ). Dietary sodium intake (mmol/day) months Figure 1 Dynamic changes in dietary sodium intake seen at follow-up. P <.5 vs. adding K and Ca group and control group. P <.5 vs. baseline ( month). Urinary sodium excretion (mmol) months The dynamic changes of BP in family members noted in year follow-ups are shown in Figure 5. The BP reduction in the added-potassium-and-calcium group was 5. mm Hg for and 3. mm Hg for (. and.%, respectively). In the salt-restricted group, the reductions were 5. and. mm Hg for and (5. and 3.1%), respectively. In contrast, there were 1.1 mm Hg () and.9 mm Hg () Figure Changes in overnight 8-h urinary sodium excretion seen at followup. P <.5 vs. added-k-and-ca group and control group. P <.5 vs. baseline ( month). Urinary potassium excretion (mmol) months Figure 3 Changes in overnight 8-h urinary potassium excretion during the follow-ups. P <.5 vs. salt-restricted group and control group. P <.5 vs. baseline ( month). AMERICAN JOURNAL OF HYPERTENSION VOLUME NUMBER 9 september 9 95 Downloaded from

4 Salt Substitute and Blood Pressure 1 subjects was more greater than those in the non-salt-sensitive (NSS) group (Figure ). There were 1.1/5.5 mm Hg reductions in SS subjects and 3./1.1 mm Hg reductions in NSS subjects (P <.5) in the added-potassium-and-calcium, and there were 7.9 mm Hg reduction of in SS subjects vs.. mm Hg reduction of (P <.5) in the salt-restricted group. Adverse reaction There were no reports of adverse events among the three groups during follow-up. No episodes of severe hyperkalemia, hypercalcemia, or kidney calculi were recorded. Figure Changes in blood pressure in adolescents with high blood pressure after -year intervention. P <.5 vs. control group. P <.1 vs. control group., diastolic blood pressure;, systolic blood pressure. 1 elevations in the control group (1.7 and 1.1%, respectively). Compared with the changes in the control group, there were significant differences (P <.5). In total, 79 adolescents were determined to be salt sensitive. Of those, 1 were in the salt-restricted group and 37 were in the added-potassium-and-calcium group. Further subgroup analysis showed that the BP reduction in the salt-sensitive (SS) Figure 5 Changes in blood pressure in total family members after -year intervention. P <.5 vs. control group. P <.1 vs. control group., diastolic blood pressure;, systolic blood pressure SS NSS Figure Changes in blood pressure in adolescents with and without salt sensitivity after -year intervention. SS, salt-sensitivity; NSS, non-salt-sensitivity;, systolic blood pressure;, diastolic blood pressure. P <.5 vs. NSS. Discussion The diet of Chinese people, especially in the rural areas of northern China, is characterized by a high sodium intake, but an insufficient intake of potassium and calcium. 1 It has been established that potassium has an important role in BP control, 5, and potassium supplementation has an antagonist effect to sodium through sodium and potassium interreaction. 15 Calcium plays a role in BP regulation, but the importance of supplemental calcium intake for the prevention of hypertension is debated. A recent meta-analysis showed that the effects of calcium supplementation on BP were somewhat larger in people with a relatively low calcium intake (8 mg/ day), that is, reduction of.3 mm Hg for and 1.3 mm Hg for. 1 Therefore potassium and calcium supplementation may be an approach for the care of BP, especially in those with an insufficient intake of potassium and calcium. The antihypertensive effects of potassium and calcium supplementation in patients with essential hypertension have been demonstrated. 15,1 The China Salt Substitute Study, which tested the effects of a salt substitute (with reduced sodium and added potassium) on BP in high-risk rural northern Chinese adults, showed that a significant and sustained reduction in could be achieved. 17 However, there have been few clinical or epidemiological studies of the effect of potassium and calcium supplementation on BP in adolescents. In our previous study, 1 we carried out a trial among school children, aged 9 13 years, to explore the effect of school-based primary care of hypertension with potassium and calcium supplementation; mmol of potassium and 7.5 mmol of calcium, in capsules, were given to children under the supervision of a teacher every morning for years. The results suggested that a moderate increase of calcium and potassium intake in schoolchildren could delay or limit the rise of BP with age, and that schoolbased primary care of hypertension would be an effective approach in China. This study indicates that either adding potassium and calcium to dietary salt or restricting of salt can decrease BP in adolescents, as well as in their related family members, especially for those with salt sensitivity. Moreover, the effects on BP of adding potassium and calcium to dietary salt were similar to those of salt restriction on BP for the adolescents and that related family members, and with better compliance. Many subjects with hypertension will not give up the taste of regular salt and consequently are unable to sufficiently reduce their salt intake, 9 september 9 VOLUME NUMBER 9 AMERICAN JOURNAL OF HYPERTENSION Downloaded from

5 Salt Substitute and Blood Pressure even though sodium restriction is widely recognized as the best nonpharmacological approach to the prevention and treatment of hypertension.,3,18 Compliance with a low-salt diet is particularly difficult for people in northern China because their diet is high in salt. Therefore, potassium and calcium supplementation, by adding it to cooking salt, is a feasible approach for control of BP in those with a high salt diet in and insufficient potassium and calcium. The sodium/potassium ratio is believed to be more important than the absolute amount of digested salt. Potassium and calcium seem to have antihypertensive effects 19 and other cardiovascular benefits. In humans, the response of BP to salt loading has been used to determine salt sensitivity. A person with salt sensitivity, if exposed to a long-term high-salt diet, will develop high BP. 1 Our previous study indicated that about 8% of adults in the general population and % of hypertensives in China were salt sensitive. In this study, 37.% of enrolled adolescents with high BP were salt sensitive. Generally, BP in SS subjects was more responsive to salt restriction than were NSS subjects. Our study found that the BP decrease in SS subjects was greater than in the NSS subjects, in both the added-potassium-and-calcium group and the salt-restricted group. This suggests that the effects on BP of potassium and calcium supplementation are similar to those of salt restriction, especially in persons with salt sensitivity. In the Chinese countryside, household cooking is a determining factor in individual salt intake as well as that of potassium and calcium. To our knowledge, no other family-based intervention with potassium and calcium supplementation has been conducted in adolescents with high BP in China, whose diet is traditionally low in potassium and calcium. Therefore, family-based primary prevention of hypertension by adding potassium and calcium to cooking salt, like restriction of salt intake, seems to be a suitable approach for BP control, and should be promoted widely to the Chinese community. Acknowledgments: This work was supported by grants from the National Health Ministry of China. Disclosure: The authors declared no conflict of interest. 1. Department of Disease Control and Prevention, Ministry of Health. Report on Chronic Diseases in China. Chinese Centre for Disease Control and Prevention: Beijing, China,.. European Society of Hypertension-European Society of Cardiology Guidelines Committee. 3 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 3; 1: World Health Organization. World Health Report : Reducing Risk, Promoting Healthy Life. World Health Organization: Geneva,.. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 3; 89: Geleijnse JM, Kok FJ, Grobbee DE. Blood pressure response to changes in sodium and potassium intake: a meta-regression analysis of randomized trials. J Hum Hypertens 3; 17: Naismith DJ, Braschi A. The effect of low-dose potassium supplementation on blood pressure in apparently healthy volunteers. Br J Nutr 3; 9: Whelton PK, He J, Cutler JA, Brancati FL, Appel LJ, Folmann D, Klag MJ. Effects of oral potassium on blood pressure: meta-analysis of randomized controlled trials. JAMA 1997; 77: Bucher HC, Cook RJ, Guyatt GH, Lang JD, Cook DJ, Hatala R, Hunt DL. Effects of dietary calcium supplementation on blood pressure: a meta-analysis of randomized controlled trials. JAMA 199; 75: Hamet P. The evaluation of the scientific evidence for a relationship between calcium and hypertension. J Nutr 1995; 15( Suppl):311s s. 1. van Mierlo LAJ, Arends LR, Streppel MT, Zeegers MP, Kok FJ, Grobbee DE, Geleijnse JM. Blood pressure response to calcium supplementation: a metaanalysis of randomized controlled trials. J Hum Hypertens ; : Whelton PK, He J, Appel LJ, Cutler JA, Havas S, Kotchen TA, Roccella EJ, Stout R, Vallbona C, Winston MC, Karimbakas J; National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from the National High Blood Pressure Education Program. JAMA ;88: Liu Zhiquan, Mu Jianjun, Liang Yimu, Chaofeng S, Dingyi Y, Xianglin X, Jun Y. Reduction of blood pressure with calcium and potassium supplementation in children: a randomized double-blind placebo controlled trial of two years. J Chin Circ 199; 11: Galletti F, Ferrara I, Stinga F, Iacone R, Noviello F, Strazzullo P. Evaluation of a rapid protocol for the assessment of salt sensitivity against the blood pressure response to dietary sodium chloride restriction. Am J Hypertens 1997;1:. 1. Ge KY, Chang SY. Dietary intake of some essential micronutrients in China. Biomed Environ Sci 1; 1: Gu DF, He J, Wu XG, Duan XF, Whelton PK. Effect of potassium supplementation on blood pressure in Chinese: a randomized placebo-controlled trial. J Hypertens 1; 19: Lasaridis AN, Kaisis CN, Zananiri KI, Syrganis CD, Tourkantonis AA. Increased natriuretic ability and hypotensive effect during short-term high calcium intake in essential hypertension. Nephron 1989; 51: The China Salt Substitute Study Collaborative Group. Salt substitution: a lowcost strategy for blood pressure control among rural Chinese. A randomized, controlled trial. J Hypertens 7; 1: World Health Organization. Diet, nutrition and the prevention of chronic diseases. Technical report series 91, Pool PE. The case for metabolic hypertension: is it time to restructure the hypertension paradigm? Prog Cardiovasc Dis 1993; 3: Adrogué HJ, Madias NE. Sodium and potassium in the pathogenesis of hypertension. N Engl J Med 7; 35: Weinberger MH. Salt sensitivity of blood pressure in humans. Hypertension 199; 7: Zhiquan Liu. Salt sensitivity and hypertension. Chin Heart J : 1:3 35. AMERICAN JOURNAL OF HYPERTENSION VOLUME NUMBER 9 september 9 97 Downloaded from

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