StrokePhase 2/3NCT00163007
Nutritional Therapy for Stroke Patients
A Phase 2/3 study testing Nutritional support in people with Stroke and Malnutrition, run by Ostfold Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Malnutrition, Weight Loss
- What is being tested?
- Nutritional support
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Jun 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subarachnoidal bleeding and planned operation
- Severe dementia
- Reduced consciousness
- Immobility
- Expected short-time survival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
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.
Read the 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.
- Conditions
- Stroke, Malnutrition, Weight Loss, Dysphagia
- Being tested
- Nutritional support
- Medical subject headings
- Stroke, Malnutrition, Weight Loss, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supportProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Truls Hauge, PhD, Study chair, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163007
- Sponsor's protocol ID
- 297
- Status last verified
- May 2009
- First submitted
- 9 Sep 2005
- Last updated
- 11 May 2009
- Results posted
- No
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.
PubMed 20955603Ha 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.
PubMed 20176418
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
- ClinicalTrials.gov ID
- NCT00163007
- Acronym / sponsor ID
- 297
- Conditions
- Stroke, Malnutrition, Weight Loss, Dysphagia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- May 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Subarachnoidal bleeding and planned operation
- Severe dementia
- Reduced consciousness
- Immobility
- Expected short-time survival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional support | Procedure or surgery | – |
Primary outcome
Percentage of patients with weight loss >=5 % at three month follow-up.
1 secondary outcome
Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2009.
- Derived from this study: PubMed 20955603Ha 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.
- Derived from this study: PubMed 20176418Ha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truls Hauge, PhD study chair
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nutritional support in people with Stroke and Malnutrition, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with weight loss >=5 % at three month follow-up.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00163007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2009; AzTrials last refreshed its copy on 29 Oct 2026.