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 clients who function the key study group completed during the the very least the latest midpoint hypertension dimensions. Seven customers was indeed taken on the demo due to a good diastolic blood pressure levels >102 mm Hg (seven in advance of and you can step one following the midpoint specifications); dos of these have been choosing placebo, step 3 was indeed getting calcium and you Buddhist singles dating sites may potassium, 2 was in fact receiving potassium and magnesium, and you will 1 is actually getting calcium and magnesium. 7 people left new demo for personal factors until the midpoint, and 5 a lot more people left prior to getting closure specifications. There had been 82 (66%) males and you can 43 (34%) women; 81 (65%) were white, 34 (27%) had been black, cuatro (3%) had been Latina, and you may six (5%) have been Far-eastern. The imply years try 53 ages (range, 25 in order to 66 many years) (Table 1 ). That patient on the calcium and you may magnesium classification, step one diligent regarding potassium and you may magnesium group, and you can not one regarding other a couple teams got prior to now drawn antihypertensive medication.
There are zero significant variations among procedures teams for the gender, race, age, body mass index, or puffing (Dining table step 1 )
On baseline, imply daily dietary consumption is 782±477 mg (19±thirteen mmol) calcium, 284±79 milligrams (12±5 mmol) magnesium, and you will 2770±802 mg (77±32 mmol) potassium. Claimed consumption of all around three diet along with of your energy had a tendency to disappear moderately into the demo in all teams having no factor one of the four communities (Dining table dos ). Baseline urinary excretion of calcium supplements, magnesium, and potassium is actually comparable along side four therapy groups (Dining table step 3 ). Urinary excretion away from calcium supplements increased significantly regarding the a few groups exactly who acquired calcium when compared to new placebo classification. Simultaneously, potassium excretion more than doubled throughout the one or two teams exactly who received potassium medications, and you will magnesium removal more than doubled regarding calcium and magnesium group (Desk step three ). The rise inside the magnesium excretion regarding potassium and magnesium classification don’t reach mathematical benefits. According to pill matters, new customers took up to 95% of their tasked pills regarding the demonstration.
Mean hypertension on standard is 139±twelve mm Hg systolic and 90±cuatro mm Hg diastolic towards the patients exactly who finished the latest demo and you may are equivalent one of the four organizations (Table cuatro ). Blood circulation pressure reduced somewhat of the three to five mm Hg within the the newest teams assigned to placebo, potassium and you can magnesium, and you may calcium and you can potassium, while the blood pressure levels lack of the newest calcium and you will magnesium class, around 1 mm Hg, is nonsignificant. There have been zero tall variations in change in blood circulation pressure ranging from for every cures classification and also the placebo classification. The outcome was in fact unaffected of the adjusting the fresh blood pressure level distinctions to have nonsignificant inaccuracies in the standard qualities, along with diet intake and you can urinary electrolyte removal.