| Methods |
Method of randomisation: opaque sealed envelope‐ allocation concealment: A
Assessor blinding: unclear for some outcomes
Intention to treat: carried out
Lost to follow‐up: intervention 1; control 2
Timing of the intervention: 6 months |
| Participants |
Location: Stockholm, Sweden
Period of study: Prior to October 2002
Number of patients: 40
Inclusion criteria: Females with acute femoral fracture, > 70 years, BMI less than or equal to 24 kg/m2, absence of severe cognitive disfunction, independent living status and independent walking capability with or without walking aids
Exclusion criteria: Patients with fractures not suitable for internal fixation and patients with rheumatoid arthritis or radiographic osteoarthritis
Sex: 40 female
Age: 83.5 (SD 6.1), 84.1 (SD 4.3) |
| Interventions |
a: Fortimel 200 ml/day, 20 g Protein, plus 1g Calcium and 400 IU Vitamin D
b: usual nutritional care plus1g Calcium and 400 IU Vitamin D
Allocated: 20/20
Assessed: 18/17 |
| Outcomes |
Length of follow‐up: 12 months
Main outcomes: mortality, length of hospital stay during first year after surgery, complications, mobility, activities of daily living, hand grip strength, adverse effects, quality of life
Additional outcomes: compliance
Measures of nutritional status‐ weight, LBM |
| Notes |
Also looked at the effects of nandrolone in a third arm of the trial
Classified as undernourished, acute admission and living in the community.
Further details required regarding details of intervention |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
