Gillman 1995.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled trial The trial was conducted in the United States of America. |
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Participants | 101 5th‐grade students Gender: 50 girls and 51 boys Ethnicity: 61 were black. Setting: inner city school |
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Interventions | Intervention: 480 mL of juice containing 600 mg calcium (as calcium citrate malate) daily Control: Same juice with no calcium Trial duration: 12 weeks |
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Outcomes | "Blood pressure 4 times on each of 3 weekly sittings at baseline and at follow‐up" | |
Notes | Nutrient data from 3 sets of 2‐day food records on each participant Funding: Procter and Gamble Co |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation was performed by a centralised unit with the ID numbers that researchers provided. ID labels were affixed to each 'juice box', and sent to researchers who were completely blinded to treatment assignment. |
Allocation concealment (selection bias) | Low risk | Random allocation was performed by a centralised unit with the ID numbers that researchers provided. ID labels were affixed to each 'juice box' and sent to researchers who were completely blinded to treatment assignment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All investigators and participants were masked to treatment assignment throughout the intervention period. "The intervention and placebo beverages were formulated to look and taste the same". "Single‐serving containers ("juice boxes") and labelled with the subject's name and study identification number" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Automated device (Dinamap Vital Signs Monitor model 845‐A, Critikon, Inc., Tampa, Fla.)". "Blood pressure data were automatically recorded on a floppy disk; investigators and participants were masked to these data until the end of the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 106 participants randomised, 5 moved from the school and the analyses included 101 participants. Age, sex, and race of non‐participants and those who dropped out before intervention were similar. |
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 in baseline systolic blood pressure, hours of television watched, and amount of dietary calcium. |