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 “Overall 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.
Results
The fresh 125 people exactly who mode the key analysis classification accomplished during the least the latest midpoint blood pressure levels specifications. Seven clients was in fact withdrawn from the demonstration because of an effective diastolic blood pressure level >102 mm Hg (eight before and you will step one after the midpoint specifications); dos of them was researching placebo, step three was indeed searching calcium and you can potassium, dos have been choosing potassium and you will magnesium, and you can step 1 was finding calcium and you will magnesium. Eight customers left the newest trial private reasons before the midpoint, and you may 5 extra people remaining prior to getting closing measurements. There have been 82 (66%) people and you may 43 (34%) women; 81 (65%) was indeed white, 34 (27%) had been black, 4 (3%) was indeed Hispanic, and you can 6 (5%) was in fact Asian. The suggest many years is actually 53 decades (diversity, twenty five so you’re able to 66 decades) (Table step one ). You to definitely patient on calcium supplements and you will magnesium class, step 1 diligent throughout the potassium and you may magnesium category, and you will none from the almost every other a few organizations had in earlier times taken antihypertensive cures.
There are no tall differences among the cures communities into the sex, competition, many years, bmi, or puffing (Dining table 1 )
At the baseline, suggest every day weightloss consumption are 782±477 milligrams (19±thirteen mmol) calcium, 284±79 milligrams (12±5 mmol) magnesium, and you may 2770±802 milligrams (77±thirty-two mmol) potassium. Stated consumption of the many around three nourishment and of your time tended to decrease averagely within the trial throughout groups having no factor among the many five teams (Desk 2 ). Baseline urinary excretion from calcium supplements, magnesium, and you will potassium are similar along the four therapy groups (Table step 3 ). Urinary removal of calcium supplements more than doubled regarding one or two teams who received calcium supplements when comparing to the new placebo classification. Additionally, potassium removal more than doubled in the a couple of groups whom acquired potassium pills, and you may magnesium excretion more than doubled on calcium and you can magnesium category (Dining table 3 ). An upswing for the magnesium removal from the potassium and you may magnesium group don’t achieve analytical advantages. Centered on pill counts, the newest clients grabbed whenever 95% of their tasked pills on trial.
Indicate blood pressure level during the standard try 139±a dozen mm Hg systolic and 90±cuatro mm Hg diastolic towards the patients who done the latest trial and you will is actually equivalent one of several five organizations (Desk 4 ). Blood pressure levels decreased somewhat because of the 3 to 5 mm Hg inside the latest communities allotted to placebo, potassium and you can magnesium, and you may calcium supplements and you can potassium, while the latest hypertension reduction in the latest calcium and you will magnesium classification, around step 1 mm Hg, is nonsignificant. There were zero tall differences in improvement in hypertension between for every single medication group and the placebo group. The outcomes was in fact unchanged by the changing the newest hypertension differences to possess nonsignificant discrepancies for the standard qualities, plus weightloss Pittsburgh hookup consumption and urinary electrolyte excretion.