- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Limburg
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Maastricht, Limburg, Nederland, 6202 AZ
- Rekruttering
- Maastricht University Medical Center
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Ta kontakt med:
- Leopold MG Curfs, Professor
- Telefonnummer: +31433877850
- E-post: Leopold.Curfs@GEN.unimaas.nl
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Hovedetterforsker:
- Nicky SJ Halbach, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Complex multiple disabilities
People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studieleder: Leopold MG Curfs, Professor, Maastricht University Medical Center
- Studieleder: Eric EJ Smeets, MD, Maastricht University Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NL32655.068.10
- MEC 10-2-043 (Annen identifikator: Medical Ethical Committee University Hospital Maastricht)
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