A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly|
- Body weight [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]Body weight is measured to the nearest 0·01 kg using Seca clinical scales. If weight could not be measured accurately, recalled weight is used (Elia, 2003; Stratton et al. 2003a).
- Skinfold thickness [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]Triceps skindfold thickness, mid arm circumference will be measured at above time points
- Handgrip strength [ Time Frame: Baseline, week 4 and week12 ] [ Designated as safety issue: No ]Muscle grip strength will be measured at above time points
- Blood Albumin [ Time Frame: Baseline, week 4 and week12 ] [ Designated as safety issue: No ]
- Barthel Score [ Time Frame: Baseline & week12 ] [ Designated as safety issue: No ]Instrumental for assessing activities daily living
- Number of visits to general practitioner/polyclinic [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Above data will be collected at the end of the study
- Hospital readmission [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Above data will be collected at the end of the study
- Acceptability of nutritional supplements [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Above data will be collected at the end of the study
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Dietary Supplement: Nutritional Supplement (Ensure Plus)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190969
|Principal Investigator:||Lee Boo Tan, BSc, MSc||Dietetics & Nutrition Services, Singapore General Hospital|