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. 2015 Jun 30;2015(6):CD010037. doi: 10.1002/14651858.CD010037.pub2
Methods Randomised, double blind parallel group trial.
The trial was conducted in the United States of America.
Participants 321 participants 93% completed baseline and midpoint measurements.
"Exclusion criteria included reported diastolic blood pressure 65 mm Hg; hypertension; BMI > 32 kg/m²; insulin‐dependent diabetes; cardiovascular disease; renal failure; medications that affect blood pressure, weight loss diets, use of nutritional supplements of calcium, magnesium, or potassium (including antacid preparations)."
Interventions Intervention group: calcium carbonate 1200 mg daily (Caltrate 600 mg twice daily, Lederle Laboratories).
Control group:identical placebo.
Trial duration: 16 weeks.
"The placebo group received twice the number of participants as the four treatment groups to improve statistical power."
Outcomes Ambulatory 24‐hour blood pressure
24‐hour urine
Body weight
Health and side effects questionnaire
Pill counts
Notes Participants who had baseline systolic blood pressure above 160 mmHg or diastolic blood pressure above 95 mm Hg were excluded and advised to see their physicians.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation was performed by a computer programme directed by the statistician on the project. The statistician had no contact with the data collectors or the participants. (Information provided by the author)
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes Low risk Participants were under double‐blind conditions for 16 weeks but methods not describe. The participants were not informed about their specific supplement group.
Blinding of outcome assessment (detection bias) All outcomes Low risk The blood pressure machine automatically entered the blood pressure data on computer tape that was later converted to an ASCII file at the study office.
Incomplete outcome data (attrition bias) All outcomes Unclear risk 321 participants were randomised. 300 participants were available for follow‐up measurements and 290 completed the study measurements.
Selective reporting (reporting bias) Low risk Primary outcome reported.
Other bias Low risk Baseline characteristics were similar.