Reid 2010.
Study characteristics | ||
Methods | Randomised controlled trial The trial was conducted in New Zealand. |
|
Participants | 323 healthy men Age: over 40 years |
|
Interventions | Intervention groups: group 1: 600 mg calcium a day or group 2: 1200 mg calcium a day as calcium citrate Control group: placebo Trial duration: 2 years |
|
Outcomes | Primary endpoint: change in the ratio of HDL to LDL cholesterol Secondary endpoints: changes in cholesterol fractions, triglycerides, blood pressure, and body composition |
|
Notes | This study was supported by Mission Pharmacal. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Treatments were allocated randomly by using computer‐generated random numbers (Microsoft Excel 2003; Microsoft, Redmond, WA) within blocks of random sizes in multiples of 3". |
Allocation concealment (selection bias) | Low risk | "Randomization was performed before the study began by the study statistician and was conveyed to a staff member who dispensed the study medication into numbered containers. This individual had no direct contact with other study staff nor with trial participants. Subjects were allocated a study number according to the sequence of their enrolment". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and study staff were blinded to treatment allocation throughout the study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Blood pressure was measured by using a Dinamap automatic monitor (Johnson & Johnson, Tampa, FL)". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Complete follow‐up was achieved in 96% of the participants, and the proportions of those randomly assigned still receiving the trial medication at study end were as follows: 93% in the placebo group, 91% in the Ca600 group, and 86%in the Ca1200 group (P = 0.19 for between‐group comparisons)". |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk | There were small differences (in different directions) between intervention and placebo participants. |