The data was reviewed during the Complimentary Center with the statistical analysis system

The data was reviewed during the Complimentary Center with the statistical analysis system

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.


The fresh new 125 customers who means the key investigation class done within minimum the midpoint blood circulation pressure dimensions. Seven people had been taken on demo because of a beneficial diastolic blood pressure >102 mm Hg (7 just before and you may step one pursuing the midpoint proportions); dos ones was basically searching placebo, step 3 was acquiring calcium and you will potassium, 2 was indeed getting potassium and you may magnesium, and you can step one is actually choosing calcium and you can magnesium. Seven clients leftover the fresh new demonstration for personal causes through to the midpoint, and you will 5 extra clients leftover before delivering closing specifications. There were 82 (66%) boys and 43 (34%) women; 81 (65%) was indeed white, 34 (27%) was in fact black colored, 4 (3%) had been Hispanic, and you can 6 (5%) was in fact Western. Its mean years is actually 53 decades (diversity, twenty-five so you can 66 years) (Dining table step one ). You to patient throughout the calcium supplements and you will magnesium classification, step one diligent in the potassium and you will magnesium class, and you may nothing on the other a couple of teams had prior to now pulled antihypertensive therapy.

There have been zero significant variations among the treatment groups into the intercourse, battle, age, bmi, or smoking (Desk step 1 )

On standard, mean each day losing weight consumption is 782±477 milligrams (19±thirteen mmol) calcium supplements, 284±79 mg (12±5 mmol) magnesium, and you can 2770±802 mg (77±32 mmol) potassium. Advertised intake of all about three nourishment in addition to of time tended to drop off averagely for the demo in most teams with no significant difference among four organizations (Desk 2 ). Standard urinary removal out-of calcium supplements, magnesium, and potassium was equivalent along side four treatment organizations (Desk step 3 ). Urinary removal of calcium increased significantly from the one or two teams which gotten calcium supplements when compared with the newest placebo classification. At exactly the same time, potassium excretion increased significantly in the two communities exactly who obtained potassium medications, and you can magnesium excretion more than doubled regarding calcium and you may magnesium category (Dining table step three ). An upswing when you look at the magnesium excretion on the potassium and magnesium classification failed to get to analytical importance. Based on tablet matters, new clients took whenever 95% of their tasked pills throughout the demonstration.

Imply blood pressure in the baseline is 139±12 mm Hg systolic and you may 90±cuatro mm Hg diastolic into the clients just who accomplished the fresh demo and is actually equivalent one of many four groups (Dining table cuatro ). Blood pressure decreased rather because of the three to five mm Hg for the the new communities assigned to placebo, potassium and you may magnesium, and you can calcium and you can potassium, while the latest blood pressure levels loss of the calcium and you can magnesium classification, whenever step 1 mm Hg, is actually nonsignificant. There have been zero high differences in change in blood pressure anywhere between for each and every cures category and also the placebo category. The outcome were unaffected by changing the fresh new hypertension distinctions for nonsignificant inaccuracies within the baseline qualities, along with weight-loss consumption and you may urinary electrolyte removal.

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