Clinical trial NCT01190969: A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
Official title: A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malnutrition
Keywords: Elderly
malnutrition
nutritional supplement
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2010-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether short-term use of oral nutritional supplements as part of the diet improves nutritional and functional status of post-hospitalization malnourished elderly.

Detailed description: Nutritional supplements have been shown to improve energy, protein, micronutrients intake, maintain or improve nutritional status in hospitalized malnourished elderly patients. However, its use in the elderly post-hospitalization is unknown, particularly in the local setting. This randomized controlled trial aims to investigate if provision of short term nutritional supplements to elderly malnourished patients after discharge from hospital improves nutritional status parameters. In addition, the impact of nutritional supplements on functional status, clinical outcome in terms of hospital readmission, number of visits to general practitioner/polyclinic and the acceptability of nutritional supplement in elderly are also examined. In this study, malnourished elderly subjects \>65 years old identified by Malnutrition Universal Screening Tool from geriatric ward 63C will be recruited within 24 to 48 hours before discharge. They will be randomized into either intervention or control group. Subjects in the intervention group will receive nutritional supplements of 600 to 900 kcal as part of regular diet. As for the control group, these similar calories will be recommended from food fortification, as part of the standard care during diet counseling, to come from food. Both group subjects receive individualised assessment by the Dietitian. At baseline, nutritional status parameters such as weight, height, body mass index, skinfold thickness, handgrip strength, albumin and functional status will be measured. Subjects are then followed up at outpatient dietitian clinic 4 and 12 weeks from hospital discharge. Albumin test will be repeated at week 4 and week 12. They will keep a three-day food record end of week 1, week 4 and week 12 in order to assess their food and nutritional supplements intake. Compliance will be monitored from food diaries and interview. At the end of week 12, the same nutritional parameters will be re-evaluated for both groups. In addition, the number of hospital admissions, visits to the general practitioner/polyclinic and the acceptability of nutritional supplements will be determined. The results from this study will guide future nutritional interventions for the malnourished elderly post-hospital discharge.

Eligibility criteria: Inclusion Criteria:

* over the age of 65 years old and to be discharged from Geriatric ward
* malnourished screened by Malnutrition Universal Screening Tool

Exclusion Criteria:

* are uncommunicative
* have a history of diabetes, chronic renal failure, liver disease
* are from long term residential homes like nursing homes
* incapable of taking study supplements to provide a minimum of 600 kcal/day as part of food intake
* intolerant to any of the ingredients in the study nutritional supplements
* require parenteral nutrition or enteral feeds as sole source of nutrition, e.g. patients who discharge home with tube feeding

Primary outcomes:
measure: Body weight
timeFrame: Baseline, week 4 and week 12
Secondary outcomes:
measure: Skinfold thickness
timeFrame: Baseline, week 4 and week 12
measure: Handgrip strength
timeFrame: Baseline, week 4 and week12
measure: Blood Albumin
timeFrame: Baseline, week 4 and week12
measure: Barthel Score
timeFrame: Baseline & week12
measure: Number of visits to general practitioner/polyclinic
timeFrame: Week 12
measure: Hospital readmission
timeFrame: Week 12
measure: Acceptability of nutritional supplements
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Dietetics & Nutrition Services, Singapore General Hospital
name: Lee Boo Tan, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: