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Malnutrition in People With Complex Multiple Disabilities

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ClinicalTrials.gov Identifier: NCT01239329
Recruitment Status : Unknown
Verified February 2011 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : November 11, 2010
Last Update Posted : February 17, 2011
Sponsor:
Collaborators:
Stichting Pergamijn (Gouverneur Kremers Centrum/azM)
Koraalgroep(Gouverneur Kremers Centrum/azM)
Lunetzorg (Gouverneur Kremers Centrum/azM)
Information provided by:
Maastricht University Medical Center

Brief Summary:

Underweight is more prevalent in people with a mental handicap than in people without a mental handicap, especially in people with a severe mental handicap. It is unknown if these people are malnourished. There is no validated screening instrument available to determine the nutrition status in people with complex multiple disabilities. Research regarding malnutrition based on body composition and nutrients in stead of anthropometric data is important.

The aim of the study is to understand the nutritional status of people with complex multiple disabilitiest through measurement of body composition and nutritients. The primary objective of the study is: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? Understanding the nutritional status of these patients is important in order for them to receive appropriate and effective treatment. This treatment is of interest for general health and the quality of daily life.


Condition or disease
Complex Multiple Disabilities Malnutrition

Study Type : Observational
Estimated Enrollment : 125 participants
Time Perspective: Cross-Sectional
Official Title: Understanding of Malnutrition in People With Complex Multiple Disabilities
Study Start Date : February 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort
Complex multiple disabilities
People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.)



Primary Outcome Measures :
  1. What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? [ Time Frame: One hour ]
    Concerning measurement of body composition, the Deuterium dilution method will be used. A blood sample will be collected for measurement of nutrients. Furthermore, clinical parameters (weight, height and abdominal girth) will be measured.


Biospecimen Retention:   Samples Without DNA
Blood as well as urine samples will be collected. Urine samples are important concerning measurement of body composition according to the Deuterium dilution method. A blood sample will be collected for measurement of nutrients.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
125 people with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC).
Criteria

Inclusion Criteria:

  • Person with complex multiple disabilities;
  • Living in a care institution participating in the Governor Kremers Centre (GKC);
  • Chronically confined to a wheelchair or bedridden;
  • 18+ years

Exclusion Criteria:

  • Parenteral nutrition;
  • Serious infection;
  • Terminal illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239329


Contacts
Contact: Nicky SJ Halbach, MD +31433872034 nicky.halbach@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Leopold MG Curfs, Professor    +31433877850    Leopold.Curfs@GEN.unimaas.nl   
Principal Investigator: Nicky SJ Halbach, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Stichting Pergamijn (Gouverneur Kremers Centrum/azM)
Koraalgroep(Gouverneur Kremers Centrum/azM)
Lunetzorg (Gouverneur Kremers Centrum/azM)
Investigators
Study Director: Leopold MG Curfs, Professor Maastricht University Medical Center
Study Director: Eric EJ Smeets, MD Maastricht University Medical Center

Responsible Party: Prof. dr. L.M.G. Curfs, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01239329     History of Changes
Other Study ID Numbers: NL32655.068.10
MEC 10-2-043 ( Other Identifier: Medical Ethical Committee University Hospital Maastricht )
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by Maastricht University Medical Center:
Complex multiple disabilities
Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders