Nutritional Therapy for Stroke Patients

NCT00163007 | Completed Phase 2

• 1 other identifier: 297
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. The primary outcome measure is the percentage of patients with weight loss ≥ 5 % at three month follow-up.

Conditions

Stroke; Malnutrition; Weight Loss; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with weight loss >=5 % at three month follow-up.

Secondary Outcomes (1)

• Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.

Interventions

Nutritional support PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke based on clinical symptoms
• 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

You may not qualify if:

• Subarachnoidal bleeding and planned operation
• Severe dementia
• Reduced consciousness
• Immobility
• Expected short-time survival

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• University of Oslo: collaborator

Study Sites (1)

Ostfold Hospital Trust

Fredrikstad, 1603, Norway

Location

Related Publications (2)

• 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.

  PMID: 20955603 DERIVED

• 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.

  PMID: 20176418 DERIVED

MeSH Terms

Conditions

Stroke; Malnutrition; Weight Loss; Deglutition Disorders

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Truls Hauge, PhD

  Ullevaal University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 11, 2009

Record last verified: 2009-05

Locations

NO (1)