| Methods |
Method of randomisation: generated by trial statistician, sequentially numbered opaque envelopes kept in different city, phoned for randomisation
Assessor blinding: action taken to blind assessors through use of identical placebo
Intention to treat: carried out
Lost to follow‐up: intervention 0; control 0
Timing of intervention: up to four weeks duration or until death or discharge
Length of follow‐up: 6 months |
| Participants |
Location: university hospital, UK
445 patients
Inclusion criteria: acutely ill hospitalised patients aged 65y or more, able to swallow, able to sign consent
Exclusion criteria: gastric surgery, malabsorption, BMI > 40kg/m2, coma, severe dementia (Abbreviated Mental Test score < 6), malignancy, living in an institution, already taking supplements
Sex: 234 female, 211 male
Age: mean age 77y |
| Interventions |
Bottles of supplement given at 08.00 and 12.00 for 6 weeks, including in the community if out of hospital
a: 2 bottles of 200ml each, providing in total 995kcal, 50g protein and 100% of reference nutrient intake for vitamins and minerals, and standard hospital diet
b: 2 placebo bottles of 200ml each, providing in total 60kcal and no protein or micronutrients, and standard hospital diet
Allocated: 223/222
Assessed: 223/222 (at 6 months) |
| Outcomes |
Main outcomes:
Mortality
Morbidity and complications ‐ infections
Length of acute hospital stay
Readmissions
Functional status ‐ Barthel Index, cognitive function in subgroup
Additional outcomes:
Measures of nutritional status ‐ weight, mid upper arm circumference, triceps skinfold
Measures of dietary intake ‐ energy and protein intake |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
