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 “Abilities”). 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.
This new 125 people which setting the main research category complete in the minimum the new midpoint hypertension proportions. 7 customers was indeed withdrawn throughout the demo due to good diastolic blood pressure level >102 mm Hg (eight before and you may 1 pursuing the midpoint measurements); dos ones have been choosing placebo, step three were choosing calcium and potassium, dos had been acquiring potassium and magnesium, and 1 is actually acquiring calcium and magnesium. Eight customers kept the fresh new demonstration for personal reasons until the midpoint, and 5 even more people kept before delivering closing proportions. There are 82 (66%) boys and you may 43 (34%) women; 81 (65%) was indeed white, 34 (27%) had been black colored, cuatro (3%) was indeed Hispanic, and you will six (5%) was in fact Far eastern. Their indicate ages was 53 ages (variety, 25 to 66 years) (Table step 1 ). You to patient from the calcium supplements and you will magnesium classification, step 1 diligent in the potassium and you can magnesium class, and none regarding almost every other a couple communities got in past times drawn antihypertensive therapy.
There have been zero high variations one of the therapy communities during the gender, race, ages, bmi, otherwise smoking (Dining table step one )
From the standard, mean everyday diet consumption was 782±477 mg (19±thirteen mmol) best hookup website Manchester calcium supplements, 284±79 mg (12±5 mmol) magnesium, and 2770±802 mg (77±32 mmol) potassium. Advertised consumption of all about three nutrients including of your time tended to decrease reasonably inside demonstration throughout communities with no significant difference among the five teams (Desk 2 ). Standard urinary excretion of calcium supplements, magnesium, and potassium is similar over the four cures groups (Dining table step three ). Urinary excretion regarding calcium supplements increased significantly about two organizations just who acquired calcium supplements when compared with the placebo category. As well, potassium removal increased significantly in the a couple of teams exactly who received potassium medicine, and you will magnesium removal increased significantly throughout the calcium and you may magnesium classification (Desk step three ). The rise when you look at the magnesium excretion regarding potassium and you may magnesium group didn’t reach mathematical value. Considering pill counts, the brand new customers grabbed everything 95% of its tasked pills from the demonstration.
Indicate blood circulation pressure in the baseline is 139±a dozen mm Hg systolic and you can 90±4 mm Hg diastolic into patients just who done the trial and was comparable one of the five organizations (Dining table cuatro ). Blood pressure diminished rather from the less than six mm Hg inside the the fresh new organizations allotted to placebo, potassium and you can magnesium, and calcium and you will potassium, whereas the fresh blood circulation pressure reduced brand new calcium and you will magnesium group, everything 1 mm Hg, is nonsignificant. There had been no extreme differences in change in blood pressure levels ranging from for each treatment classification as well as the placebo class. The outcomes have been unaffected of the modifying the fresh new hypertension variations to have nonsignificant discrepancies inside standard characteristics, along with weight reduction consumption and you can urinary electrolyte excretion.