Barger‐Lux 2005.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group trial (2 groups) Duration of study: May 1995 to April 2000 Duration of follow‐up: 36 months |
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Participants |
Setting characteristic: open population Inclusion criteria: healthy women, non‐smoking, non‐pregnant Exclusion criteria: height and weight that yielded a BMI > 30 kg/m2, binge‐drinking, significant risk of pregnancy, or more than occasional use of calcium supplements or calcium‐containing antiacids Age: 23.1 (SD 2.7) years Sample: Total included 152 (and total report of 87 followed at 36 months) (total of both groups not specified by group)
Country: USA |
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Interventions |
Comparison: calcium versus placebo Intervention group:
Control group:
Administration: daily consumption of food Duration of treatment: 36 months |
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Outcomes | BMD: total hip and lumbar spine BMC: total body, spine L1–L4, and total hip Biomarkers: serum calcium, urine calcium |
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Notes | Other intervention: (quote) "All participants were also supplied with fully‐labeled Geritol® multivitamin tablets, to be taken once daily to ensure at least minimal status for vitamin D and other trace nutrients. Ca, placebo, and multivitamin tablets were supplied without charge by the manufacturer (SmithKline Beecham)." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified. Quote: "152 were randomly assigned to groups and entered the study." |
Allocation concealment (selection bias) | Low risk | Central allocation (pharmacy‐controlled) and sequentially numbered drug containers. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Tablets were packaged in bottles of 90 by the manufacturer; a research pharmacist selected and labeled the bottles." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study authors reported withdrawals in both groups and the reasons were not related to the intervention. At 12 months, data for 10 (12%) participants in calcium group and 21 (21%) participants in placebo group were missing. The reported reasons were pregnancy, unwillingness to follow protocol, loss of follow‐up, and others. |
Selective reporting (reporting bias) | Unclear risk | Not specified. |
Other bias | Low risk |
Baseline imbalance. Characteristics were imbalanced between groups. Quote: "The 2 groups were well matched except for urine calcium, which was significantly higher at baseline in those assigned to calcium (0.092 ± 0.007 g/g) than in those assigned to placebo (0.073 ± 0.005 g/g)." Comment: we judged this difference was not important in the study population. |