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. 2023 Jan 27;2023(1):CD012664. doi: 10.1002/14651858.CD012664.pub2

Shapses 2001.

Study characteristics
Methods Randomised, controlled, parallel‐group trial (2 groups)
Duration of study: not specified
Duration of follow‐up: 6 months
Participants Setting characteristic: participants were in a moderate weight‐loss programme
Inclusion criteria: obese healthy women; stable weight for ≥ 3 months before the start of the study
Exclusion: pregnant or lactating within the previous year; history of an irregular menstrual cycle; ill or taking medication known to interfere with bone metabolism, including oral contraceptives
Age: 42.1 (SD 6.2) years
Sample:
Total included 60
  • Calcium group (weight loss): 14 (baseline) and 14 (6 months)

  • Placebo group (weight loss): 14 (baseline) and 14 (6 months)

  • Placebo group (maintain stable weight): not specified (baseline) and 10 (6 months)


Country: USA
Interventions Intervention group:
  • calcium citrate 1000 mg


Control group:
  • placebo tablets (gift from Mission Pharmaceuticals, San Antonio, Texas, USA)


Other intervention: reduced calorie diet was then individually created using the American Diabetic Association Exchange List.
Administration: daily
Duration of treatment: 6 months
Outcomes BMD: lumbar and total body
BMC: lumbar and total body
Biomarkers: pyridinoline, deoxypyridinoline, N‐telopeptide, osteocalcin, parathyroid hormone, and 25‐hydroxyvitamin D
Intake: energy, protein, fat, carbohydrates, calcium, phosphorus, vitamin D, and magnesium.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified.
Allocation concealment (selection bias) Unclear risk Not specified.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not specified.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified.
Incomplete outcome data (attrition bias)
All outcomes High risk The analysis of the placebo group showed substantial deviations from the randomised intervention.
Selective reporting (reporting bias) High risk The groups assigned initially from the methodology, during the study were arbitrarily reassigned.
Other bias Unclear risk The final allocation did not coincide with the baseline allocation of participants.