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 “Efficiency”). 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 new 125 customers exactly who function the key investigation category accomplished within minimum new midpoint blood circulation pressure measurements. 7 patients have been withdrawn from the trial due to an effective diastolic blood circulation pressure >102 mm Hg (eight just before and you can step 1 after the midpoint measurements); dos of these have been getting placebo, 3 have been choosing calcium and you can potassium, dos were finding potassium and magnesium, and you may 1 try choosing calcium and magnesium. 7 clients kept this new trial private explanations before midpoint, and you will 5 most clients leftover just before providing closing measurements. There are 82 (66%) men and you may 43 (34%) women; 81 (65%) was indeed white, 34 (27%) were black colored, cuatro (3%) was basically Latina, and six (5%) were Far eastern. Their mean ages is actually 53 ages (variety, 25 in order to 66 ages) (Desk step 1 ). You to diligent regarding the calcium supplements and you can magnesium classification, step 1 diligent regarding the potassium and you will magnesium class, and nothing regarding the other a couple organizations got prior to now removed antihypertensive therapy.
There were no tall variations one of many treatment organizations during the intercourse, battle, decades, bmi, otherwise smoking (Table step 1 )
On standard, suggest each and every day fat reduction consumption was 782±477 milligrams (19±13 mmol) calcium, 284±79 milligrams (12±5 mmol) magnesium, and you can 2770±802 mg (77±thirty-two mmol) potassium. Reported consumption of all three nutrients together with of energy tended to fall off averagely in demonstration in every teams that have zero significant difference one of the five communities (Desk dos ). Baseline urinary removal off calcium supplements, magnesium, and you may potassium are similar across the five therapy communities (Dining table 3 ). Urinary removal of calcium increased significantly throughout the two communities who acquired calcium in comparison with the new placebo class. Likewise, potassium excretion more than doubled throughout the several teams just who acquired potassium capsules, and you may magnesium excretion increased significantly about calcium and you may magnesium category (Desk step three ). An upswing into the magnesium removal regarding potassium and you will magnesium class don’t achieve mathematical relevance. Based on pill matters, the latest clients took everything 95% of its tasked tablets from the demo.
Suggest hypertension on standard is 139±several best hookup bar Kamloops mm Hg systolic and ninety±cuatro mm Hg diastolic for the patients exactly who accomplished the newest trial and you will is similar one of the four groups (Table cuatro ). Blood circulation pressure diminished notably of the less than six mm Hg for the this new teams assigned to placebo, potassium and you can magnesium, and you will calcium and you will potassium, while the fresh new hypertension reduction in the fresh new calcium supplements and you can magnesium group, around 1 mm Hg, was nonsignificant. There have been zero significant variations in improvement in hypertension between for each therapy group and the placebo group. The outcomes had been unaffected because of the changing the fresh new blood pressure distinctions for nonsignificant discrepancies during the standard attributes, in addition to dieting intake and you may urinary electrolyte removal.