- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163007
Nutritional Therapy for Stroke Patients
Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective, short-term studies in patients admitted for acute stroke have shown an increased risk of infections, bedsores, impaired functional outcome, slower rate of recovery, poorer rehabilitation potential and higher mortality in patients with a poor nutritional status. Sixteen percent of stroke patients are already malnourished on admission to hospital. The incidence of dysphagia in patients with acute stroke ranges from 30 to 45%. Dysphagia increases the risk of developing poor nutritional status, and new cases of malnutrition develop during the hospital stay, even during the first week. In hospitals without routine nutritional assessment and individual nutrition management plans, the risk of patients developing malnutrition may be increased. In this study patients admitted for acute stroke are randomised into either receiving nutritional therapy derived from estimated individual nutritional intake and nutritional needs, or nutritional therapy based on routine care; without routine assessment of nutritional status, intake or needs. Nutritional therapy: enriched meals, sip-feedings or enteral feedings. Parameters of nutritional status: Weight, BMI, TSF thickness, mid upper arm circumference, body composition, s-albumin and s-transferrin. Estimation of nutritional intake: Daily registration of food and drink intake. Estimating functional status: Hand grip strength, Barthels ADL index and Scandinavian stroke scale. Estimating quality of life: EQ-5D.
Before the inclusion started we decided to use the percentage of patients with weight loss ≥ 5 % at 3 months follow-up as the primary outcome measure because this is correlated better to clinical outcomes as e.g. mortality and comorbidity. Secondary outcome measures were then defined as handgrip strength, quality of life, nutritional status, nutrient intake and length of hospital stay.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Fredrikstad, Norway, 1603
- Ostfold Hospital Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute stroke based on clinical symptoms
- 18 years old and above
- < 7 days since debut of stroke symptoms and either body mass index (BMI) = or < 20
- Weight loss > 5% in 3-6 months or there has been little or is likely to be no or very little nutritional intake for > 5 days
Exclusion Criteria:
- Subarachnoidal bleeding and planned operation
- Severe dementia
- Reduced consciousness
- Immobility
- Expected short-time survival
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Percentage of patients with weight loss >=5 % at three month follow-up.
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Secondary Outcome Measures
Outcome Measure |
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Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Truls Hauge, PhD, Ullevaal University Hospital
Publications and helpful links
General Publications
- Ha L, Hauge T, Iversen PO. Body composition in older acute stroke patients after treatment with individualized, nutritional supplementation while in hospital. BMC Geriatr. 2010 Oct 18;10:75. doi: 10.1186/1471-2318-10-75.
- Ha L, Hauge T, Spenning AB, Iversen PO. Individual, nutritional support prevents undernutrition, increases muscle strength and improves QoL among elderly at nutritional risk hospitalized for acute stroke: a randomized, controlled trial. Clin Nutr. 2010 Oct;29(5):567-73. doi: 10.1016/j.clnu.2010.01.011. Epub 2010 Feb 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 297
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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