- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01239329
Malnutrition in People With Complex Multiple Disabilities
Understanding of Malnutrition in People With Complex Multiple Disabilities
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Limburg
-
Maastricht, Limburg, Holland, 6202 AZ
- Rekruttering
- Maastricht University Medical Center
-
Kontakt:
- Leopold MG Curfs, Professor
- Telefonnummer: +31433877850
- E-mail: Leopold.Curfs@GEN.unimaas.nl
-
Ledende efterforsker:
- Nicky SJ Halbach, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Complex multiple disabilities
People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients?
Tidsramme: 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.
|
One hour
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Leopold MG Curfs, Professor, Maastricht University Medical Center
- Studieleder: Eric EJ Smeets, MD, Maastricht University Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NL32655.068.10
- MEC 10-2-043 (Anden identifikator: Medical Ethical Committee University Hospital Maastricht)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .