Lyle 1992.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled trial The trial was conducted in the United States of America. |
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Participants | 42 adults Gender: men and women High normal or mildly hypertensive levels of blood pressure |
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Interventions | Intervention group: 500 mg of elemental calcium as calcium carbonate tablets Control group: placebo tablets Trial duration: 8 weeks |
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Outcomes | Blood pressure | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were given a random number of calcium or placebo tablets. |
Allocation concealment (selection bias) | Low risk | The supplements were strip‐wrapped individually and coded by someone not involved in the research study. The participants did not know which group they were assigned to, and the researcher(s) who collected other information also were not aware of the group assignment. Early analyses were completed prior to revealing the assigned groups as well. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Experimental group assessment was double‐blind. Tablets contained 500 mg of elemental calcium in the form of calcium carbonate. Indistinguishable placebo tablets |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measurements were taken with a random‐zero sphygmomanometer at least 1 minute apart. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 44 men and women participants were randomised, 2 participants withdrew due to appointment conflicts and 42 participants completed the study. Missing outcome data balanced in numbers across intervention groups |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | In the treatment group, there were more men than in the placebo group. 8 of the 10 women were allocated to the placebo group. However, blood pressure measurements showed no statistically significant differences between groups. |