| Methods |
Method of randomisation: block randomisation of 100 by pharmacy, sealed envelopes, remote site
Assessor blinding: yes
Intention to treat: done
Lost to follow‐up: intervention 0; control 0 (all patients accounted for)
Timing of the intervention: whenever their clinical team allowed
Length of follow‐up: mean 14.2 (SD24.9), 11.4 (SD16.4) days |
| Participants |
Location: The Royal London Hospital and St Bartholomew's Hospital, London
549 patients
Inclusion criteria: patients admitted though acute services ‐ general medical, surgical or orthopaedic, thin but not seriously undernourished ‐ BMI 18‐22, or unintentional weight loss greater than or equal to 5%
Exclusion criteria: planned admissions to medical or orthopaedic wards, <18y, mental illness, already routine treatment with water soluble vitamins, admission clearly for 2 days or less, previously taken part in trial, BMI <18, unintentional weight loss >10%, therapeutic diets, unable to swallow liquids, randomisation clinically unacceptable, unable to gain consent
Sex: 314 female, 235 male
Age: 67/66 |
| Interventions |
a: 2 x 200ml Ensure plus, 600 kcal, 25g protein, 80.8g carbohydrate, 19.6g fat plus vitamins and minerals plus or minus a vitamin supplement
b: 400ml placebo drink 100kcal, 25g carbohydrate plus or minus a vitamin supplement
Allocated: 275/274
Assessed: 271/274 |
| Outcomes |
Main outcomes: mortality, length of hospital stay
Additional outcomes: compliance |
| Notes |
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 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
