Malnutrition in People With Complex Multiple Disabilities

Malnutrition Clinical Trial

Official title:

Understanding of Malnutrition in People With Complex Multiple Disabilities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01239329
• Other study ID #: NL32655.068.10
• Secondary ID: MEC 10-2-043
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2010
• Last updated: February 16, 2011
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2011
• Source: Maastricht University Medical Center
• Contact: Nicky SJ Halbach, MD
• Phone: +31433872034
• Email: nicky.halbach[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Complex Multiple Disabilities
• Malnutrition

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Koraalgroep(Gouverneur Kremers Centrum/azM), Lunetzorg (Gouverneur Kremers Centrum/azM), Stichting Pergamijn (Gouverneur Kremers Centrum/azM)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients?	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.	One hour	No