20 The primary outcome variable was change in diastolic blood pressure from the baseline screening visits to the https://www.datingranking.net/local-hookup/louisville/ 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 “Efficiency”). 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.
Results
The fresh new 125 customers whom form the primary research group accomplished within minimum the latest midpoint blood pressure measurements. 7 clients had been withdrawn regarding demo due to a diastolic blood pressure levels >102 mm Hg (eight prior to and you can step 1 adopting the midpoint proportions); 2 ones was indeed acquiring placebo, step three was getting calcium supplements and you can potassium, dos was basically researching potassium and magnesium, and you will step one try acquiring calcium supplements and you will magnesium. Seven people left new trial for personal factors up until the midpoint, and you can 5 most people remaining before getting closure proportions. There have been 82 (66%) guys and you can 43 (34%) women; 81 (65%) was basically light, 34 (27%) were black colored, cuatro (3%) was basically Hispanic, and you can six (5%) had been Far eastern. Their imply years are 53 ages (diversity, twenty-five in order to 66 age) (Table step 1 ). One to patient throughout the calcium supplements and magnesium class, step one patient throughout the potassium and you can magnesium category, and you may none regarding almost every other one or two groups had in the past pulled antihypertensive medication.
There had been zero tall distinctions one of several procedures organizations inside the intercourse, competition, decades, body mass index, or smoking (Table 1 )
From the standard, imply every single day dieting intake was 782±477 mg (19±13 mmol) calcium supplements, 284±79 mg (12±5 mmol) magnesium, and 2770±802 mg (77±thirty-two mmol) potassium. Advertised consumption of all the three nourishment and of time tended to decrease averagely within the demo throughout teams with zero factor one of several four teams (Dining table dos ). Standard urinary excretion out of calcium supplements, magnesium, and you can potassium is actually similar over the four medication communities (Table 3 ). Urinary removal of calcium supplements more than doubled about a couple of groups just who obtained calcium in comparison with the fresh placebo category. Additionally, potassium excretion more than doubled on a couple teams exactly who gotten potassium tablets, and magnesium removal increased significantly on the calcium and you will magnesium classification (Dining table step three ). The rise into the magnesium removal throughout the potassium and you will magnesium class don’t go statistical relevance. Predicated on pill counts, the new patients grabbed just as much as 95% of their assigned tablets regarding demo.
Mean blood pressure levels during the standard are 139±12 mm Hg systolic and ninety±4 mm Hg diastolic toward patients which finished the latest demonstration and you can was similar among five teams (Desk cuatro ). Blood pressure level diminished notably of the 3 to 5 mm Hg in brand new communities allotted to placebo, potassium and you can magnesium, and you can calcium supplements and you will potassium, whereas this new blood pressure level losing the brand new calcium and you may magnesium category, up to step one mm Hg, is actually nonsignificant. There are zero significant variations in change in blood pressure between per procedures group therefore the placebo category. The results was unchanged by the changing brand new hypertension variations having nonsignificant inaccuracies in the standard functions, including dieting consumption and you can urinary electrolyte removal.