20 The primary outcome variable was change in diastolic blood pressure from the baseline screening visits to the average of the midpoint and closing visits. Patients who withdrew from the study after the midpoint were included in the primary analysis. Blood pressure for each subject at baseline, midpoint, and closing was the average of nine measurements (three measurements on each of 3 days). The trial was designed to have at least 80% power to detect a change in blood pressure of 3 mm Hg diastolic with two-sided P<.05. The actual sensitivity of the trial for the effect of each cation combination was determined from the 95% confidence intervals of the differences in the blood pressure changes between supplement and placebo groups (for an example, see “Performance”). Multiple regression analyses determined the effect of each treatment compared with placebo using treatment group as an independent variable. Additional analyses were conducted on systolic blood pressure and on the changes at midpoint and closing, separately. Covariates were added to the multiple regression model to assess the effects of treatment in various subgroups of the patients, eg, baseline urinary electrolyte excretion. The model included treatment group, baseline urinary excretion, and the interaction term, treatment?urinary excretion. The effects of the treatments were also examined in subgroups with urinary electrolyte excretion levels above and below the median.
New 125 clients whom mode an important analysis class complete on minimum the newest midpoint blood pressure level specifications. Eight people were withdrawn in the demonstration because of a diastolic blood pressure level >102 mm Hg (seven prior to and 1 following the midpoint dimensions); dos of those was indeed finding placebo, step three was in fact searching calcium supplements and you can potassium, dos had been getting potassium and you can magnesium, and you may step one try receiving calcium supplements and magnesium. Eight clients leftover brand new demo private causes before the midpoint, and you can 5 extra patients left in advance of getting closure proportions. There were 82 (66%) guys and you can 43 (34%) women; 81 (65%) had been light, 34 (27%) hookup culture Shreveport had been black colored, cuatro (3%) were Latina, and you will six (5%) was in fact Far eastern. Their imply many years is 53 decades (range, twenty-five so you’re able to 66 age) (Table step 1 ). You to diligent on the calcium supplements and magnesium category, 1 patient about potassium and you may magnesium group, and you will nothing about other several organizations got in earlier times taken antihypertensive cures.
There had been zero high variations among cures communities inside intercourse, race, ages, body mass index, otherwise puffing (Table 1 )
In the baseline, mean every single day weight-loss consumption try 782±477 milligrams (19±13 mmol) calcium supplements, 284±79 mg (12±5 mmol) magnesium, and 2770±802 milligrams (77±32 mmol) potassium. Claimed consumption of all about three diet and additionally of energy tended to drop-off moderately from inside the trial in all organizations which have zero significant difference one of the five groups (Table dos ). Standard urinary removal away from calcium supplements, magnesium, and you will potassium try similar along the four treatment teams (Desk step 3 ). Urinary removal from calcium supplements increased significantly regarding the one or two communities just who received calcium supplements when comparing to the placebo category. Concurrently, potassium removal increased significantly on the a couple of teams just who acquired potassium pills, and magnesium excretion increased significantly regarding the calcium supplements and magnesium group (Desk 3 ). The rise for the magnesium excretion on potassium and you will magnesium group failed to go mathematical importance. Based on tablet matters, the fresh new patients took up to 95% of the assigned pills regarding demo.
Mean hypertension during the baseline are 139±several mm Hg systolic and you can 90±cuatro mm Hg diastolic with the people who finished the newest trial and you will is actually similar one of several four groups (Desk 4 ). Blood pressure diminished notably because of the 3 to 5 mm Hg inside the the groups allotted to placebo, potassium and you can magnesium, and you can calcium and you can potassium, whereas brand new blood pressure reduction in new calcium and magnesium class, approximately 1 mm Hg, are nonsignificant. There had been no extreme variations in change in blood pressure levels ranging from each procedures classification and placebo class. The results was in fact unchanged of the modifying the latest blood circulation pressure distinctions having nonsignificant discrepancies from inside the baseline services, in addition to fat reduction consumption and urinary electrolyte excretion.