| Methods |
Method of randomisation: not stated
Assessor blinding: unclear whether all or some outcomes
Intention to treat: not carried out, those unable to consume supplements not included in the analysis
Lost to follow‐up: intervention 2 withdrawn due to reluctance to take extra drinks, 1 withdrawn due to objection to being weighed and measured; control 1 withdrawn due to reluctance to take extra drinks, 2 withdrawn due to objection to being weighed and measured
Timing of intervention: 12 weeks, twice daily |
| Participants |
Location: All residents of care of the elderly wards at a large psychiatric teaching hospital, Edinburgh
46 patients
Inclusion criteria: diagnosed as having some degree of senile dementia, BMI 15.1‐19.9
Exclusion criteria: physical pathology, likely to be discharged during the study period, no consent from relatives
Sex: 36 female, 10 male
Age: men: mean age 68‐69y, women: 79‐80y
Health Status: malnourished, senile dementia |
| Interventions |
a: 200 ml oral supplement Fortisip twice daily providing 600 kcal/day in addition to normal meals
b: 200 ml oral vitamin preparation twice daily providing the same vitamins as Fortisip, but virtually no macronutrients, in addition to normal meals
Allocated: 23/23
Assessed: 20/20 |
| Outcomes |
Main outcomes:
Mortality
Additional outcomes:
Measures of nutritional status ‐ weight change, body mass index, mid upper arm circumference, triceps skinfold
Patient compliance ‐ numbers consuming all drinks offered |
| Notes |
Request for further details sent 18/9/01 on method of randomisation, blinding of outcome assessors and treatment providers and further details of anthropometry outcomes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
C ‐ Inadequate |
