Trial record 1 of 1021 for:    Open Studies | "Malnutrition"
Previous Study | Return to List | Next Study

Malnutrition in People With Complex Multiple Disabilities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01239329
First received: November 10, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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
Complex Multiple Disabilities
Malnutrition

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Understanding of Malnutrition in People With Complex Multiple Disabilities

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 125
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Complex multiple disabilities
People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 10, 2010
Last Updated: February 16, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 19, 2014