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 “Overall 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.
Results
New 125 patients who mode the main research category done within least this new midpoint blood pressure specifications. Seven patients was withdrawn about trial because of an excellent diastolic blood pressure >102 mm Hg (7 prior to and step 1 after the midpoint proportions); dos of them was in fact researching placebo, step 3 was in fact choosing calcium and you can potassium, dos were finding potassium and you can magnesium, and you will 1 is actually searching calcium supplements and you can magnesium. Eight people left the fresh new demonstration private explanations up until the midpoint, and you may 5 extra customers left in advance of taking closure proportions. There had been 82 (66%) guys and 43 (34%) women; 81 (65%) had been white, 34 (27%) was indeed black colored, cuatro (3%) had been Hispanic, and six (5%) was indeed Asian. Its mean years was 53 ages (variety, 25 to help you 66 years) (Table step 1 ). That diligent throughout the calcium and you can magnesium class, step one diligent throughout the potassium and magnesium group, and you can not one in the almost every other one or two communities had prior to now drawn antihypertensive therapy.
There were no significant distinctions among cures groups in the sex, race, many years, body mass index, otherwise smoking (Table 1 )
On standard, suggest each day dietary intake try 782±477 mg (19±13 mmol) calcium, 284±79 milligrams (12±5 mmol) magnesium, and 2770±802 milligrams (77±32 mmol) potassium. Said intake Killeen city hookup guide of all three nutrients plus of your energy tended to drop off averagely inside demonstration in every teams which have no factor one of the four communities (Dining table dos ). Baseline urinary excretion away from calcium supplements, magnesium, and you may potassium was similar over the five therapy teams (Dining table step 3 ). Urinary removal out of calcium increased significantly regarding two organizations which received calcium when compared with the fresh new placebo group. At the same time, potassium removal increased significantly on two teams just who received potassium medicine, and you will magnesium removal increased significantly on the calcium supplements and magnesium classification (Desk step 3 ). The rise when you look at the magnesium removal regarding potassium and you will magnesium group don’t go mathematical relevance. Considering pill matters, brand new people got everything 95% of the tasked tablets about trial.
Mean hypertension on standard try 139±a dozen mm Hg systolic and you may ninety±4 mm Hg diastolic on the patients who completed the latest demo and you may is actually similar among five groups (Table cuatro ). Hypertension reduced notably by three to five mm Hg when you look at the brand new organizations assigned to placebo, potassium and you can magnesium, and you will calcium supplements and you will potassium, while this new hypertension losing the fresh new calcium supplements and magnesium class, just as much as 1 mm Hg, are nonsignificant. There had been no high differences in improvement in hypertension between per cures group therefore the placebo class. The outcome was basically unaffected from the modifying the blood circulation pressure distinctions getting nonsignificant discrepancies from inside the standard qualities, along with dieting consumption and you can urinary electrolyte excretion.