Hampson 2003.
Methods | Randomised controlled trial. Duration 12 months. | |
Participants | Adult women (n = 71, dietary advice and supplement group, mean (SD) age 76 years (4.2), no advice group mean (SD) age 76.7 years (5.7)) with osteoporosis. All patients malnourished with BMI <21. 6 participants withdrew from the study, 5 in the dietary advice and supplement group. |
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Interventions | Dietary advice to increase intake and 2x 200ml supplement (Nutricia) +1 g calcium and 800 units cholecalciferol (n = 36) versus no dietary advice +1 g calcium and 800 units cholecalciferol (n = 35). | |
Outcomes | Survival*, weight*, bone mineral density, fat mass, lean mass, energy intake*. | |
Notes | Additional data on outcomes requested from author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generated in a department external to the study (Department of Public Health). |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 6 participants withdrew from the study, 5 in the dietary advice and supplement group. |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported but not in a format suitable for entry into meta‐analysis. Data on energy intake reported as mean (SD) for groups at baseline and end of intervention, therefore mean change data obtained from the authors. Data on weight change reported as % change. Data requested from authors but not received. |
Other bias | Unclear risk | Baseline variables given, treatment group were significantly lighter and had lower fat mass than the no treatment group. |