Skip to main content
. 2023 Jan 27;2023(1):CD012664. doi: 10.1002/14651858.CD012664.pub2

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
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)
  • Calcium group: 81 (baseline), 77 (2 months), and 67 (12 months)

  • Placebo group: 71 (baseline), 69 (2 months), and 54 (12 months)


Country: USA
Interventions Comparison: calcium versus placebo
Intervention group:
  • calcium carbonate 500 mg 3 capsules (1500 mg)


Control group:
  • placebo capsules identical in appearance.


Administration: daily consumption of food
Duration of treatment: 36 months
Outcomes BMD: total hip and lumbar spine
BMC: total body, spine L1–L4, and total hip
Biomarkers: serum calcium, urine calcium
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.