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.
Results
The newest 125 patients which function the primary study group done in the the very least the latest midpoint blood circulation pressure specifications. Seven clients have been withdrawn regarding demo because of a beneficial diastolic blood pressure >102 mm Hg (eight just before and step 1 following midpoint dimensions); 2 of those have been acquiring placebo, 3 have been finding calcium and you will potassium, dos was indeed choosing potassium and you may magnesium, and you can 1 is actually researching calcium supplements and you can magnesium. 7 customers remaining the new demonstration for personal explanations until the midpoint, and you can 5 additional patients leftover prior to providing closing dimensions. There have been 82 (66%) males and you can 43 (34%) women; 81 (65%) was indeed white, 34 (27%) was indeed black, cuatro (3%) was https://datingranking.net/local-hookup/jacksonville Hispanic, and you can 6 (5%) was indeed Asian. The imply years is 53 age (variety, twenty five in order to 66 age) (Table 1 ). One to diligent about calcium and you may magnesium group, step one patient on potassium and you will magnesium category, and not one throughout the almost every other a few teams got in earlier times taken antihypertensive cures.
There were zero significant variations among the treatment communities in the sex, battle, many years, body mass index, or puffing (Table step one )
On standard, indicate each day dietary intake was 782±477 milligrams (19±thirteen mmol) calcium, 284±79 mg (12±5 mmol) magnesium, and you can 2770±802 mg (77±32 mmol) potassium. Reported consumption of the many about three diet also of time had a tendency to decrease mildly for the demo in most teams with zero factor among four communities (Dining table dos ). Standard urinary removal out-of calcium, magnesium, and you can potassium are similar along side four procedures groups (Desk 3 ). Urinary excretion out-of calcium supplements more than doubled on the a couple groups whom obtained calcium when comparing to this new placebo class. At the same time, potassium removal more than doubled regarding the a couple of groups exactly who received potassium medicine, and you can magnesium excretion increased significantly about calcium supplements and you can magnesium class (Table 3 ). An upswing from inside the magnesium removal in the potassium and magnesium group didn’t get to analytical relevance. Centered on pill matters, the new people grabbed approximately 95% of their tasked tablets on the trial.
Indicate blood circulation pressure during the standard was 139±12 mm Hg systolic and you can 90±cuatro mm Hg diastolic towards the patients who done the demonstration and is equivalent among the five teams (Table cuatro ). Blood pressure reduced somewhat of the 3 to 5 mm Hg in the the fresh new organizations allotted to placebo, potassium and you may magnesium, and you can calcium supplements and potassium, while the brand new blood circulation pressure reduction in the fresh new calcium and you will magnesium group, everything step one mm Hg, was nonsignificant. There are no extreme variations in change in blood pressure anywhere between for each and every medication group plus the placebo class. The outcome was basically unchanged because of the changing this new hypertension variations getting nonsignificant discrepancies into the baseline qualities, as well as fat reduction consumption and you can urinary electrolyte removal.