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 “Results”). 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 brand new 125 clients exactly who setting the primary study class completed during the minimum brand new midpoint blood pressure dimensions. Seven patients was basically withdrawn regarding the trial due to a diastolic blood pressure levels >102 mm Hg (seven prior to and you will 1 after the midpoint proportions); dos ones had been acquiring placebo, step 3 had been choosing calcium and you can potassium, 2 was basically acquiring potassium and you may magnesium, and you will step 1 is searching calcium and you can magnesium. Seven patients leftover the newest trial for personal explanations until the midpoint, and you may 5 a lot more customers left just before bringing closing measurements. There had been 82 (66%) guys and you will 43 (34%) women; 81 (65%) was in fact white, 34 (27%) was indeed black colored, 4 (3%) was basically Hispanic, and you can six (5%) had been Far eastern. The mean years are 53 years (variety, twenty-five to help you 66 decades) (Table step 1 ). That diligent about calcium and you will magnesium category, step 1 diligent regarding the potassium and you will magnesium classification, and you may none throughout the most other a couple of communities got in earlier times pulled antihypertensive treatment.
There were zero significant variations among cures groups inside sex, competition, years, bmi, otherwise smoking (Table 1 )
From the baseline, imply each and every day weight loss consumption are 782±477 mg (19±thirteen mmol) calcium supplements, 284±79 milligrams (12±5 mmol) magnesium, and you may 2770±802 milligrams (77±thirty-two mmol) potassium. Reported consumption of the many about three nutrients as well as of time had a tendency to fall off reasonably within the demonstration in all communities with no factor one of many five communities (Desk dos ). Baseline urinary excretion out-of calcium, magnesium, and potassium is comparable along the five medication organizations (Desk step three ). Urinary excretion away from calcium increased significantly from the two teams which gotten calcium supplements in comparison to the latest placebo classification. Additionally, potassium excretion increased significantly in the a https://datingranking.net/local-hookup/chattanooga/ couple of groups whom gotten potassium medications, and you may magnesium excretion increased significantly in the calcium and you may magnesium classification (Table step three ). The rise into the magnesium excretion on the potassium and magnesium class didn’t get to mathematical benefit. Centered on pill counts, the fresh new customers took around 95% of their assigned pills throughout the demonstration.
Mean blood pressure at the standard is 139±several mm Hg systolic and you can ninety±4 mm Hg diastolic to the patients whom accomplished the demonstration and you may try similar one of the four organizations (Desk 4 ). Blood pressure level decreased significantly from the 3 to 5 mm Hg in the the new teams assigned to placebo, potassium and magnesium, and you may calcium supplements and you can potassium, whereas the brand new blood pressure levels loss of this new calcium supplements and magnesium classification, approximately step 1 mm Hg, was nonsignificant. There were zero tall differences in change in blood pressure level ranging from for each procedures class and placebo class. The results have been unaffected of the changing the fresh new blood pressure level variations getting nonsignificant inaccuracies within the standard characteristics, along with dietary intake and you may urinary electrolyte excretion.
