Undersøgelse af LYM-X-SORB™ til forbedring af fedtsyre- og cholinstatus hos børn med CF og PI
11. januar 2013 opdateret af: Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.
Fase II-studie: LYM-X-SORB™, en organiseret lipidmatrix: fedtsyrer og cholin i CF
Formålet med dette fase II forskningsstudie er at evaluere effektiviteten af næste generation af LYM-X-SORB™ til at forbedre den essentielle fedtsyre (EFA) og cholinstatus for børn og unge med cystisk fibrose (CF) og bugspytkirtelinsufficiens (PI). ).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Fedtmalabsorption er almindelig hos personer med cystisk fibrose (CF) og bugspytkirtelinsufficiens (PI). Dette sætter dem i fare for kalorie-, essentielle fedtsyre- og cholinmangel, hvilket igen kan føre til vækstsvigt og et dårligere klinisk forløb. Formålet med dette forskningsstudie er at finde ud af, hvorvidt indtagelse af LYM-X-SORB™ over en 18-måneders periode, hver dag, vil rette op på det problem, mennesker med CF og PI har med at absorbere fedt og cholin. Deltagelse vil hjælpe CF-læger og andet sundhedspersonale med at lære mere om de potentielle fordele ved LYM-X-SORB™ for børn og unge med CF og PI. Disse fordele kan omfatte bedre absorption af fedt, bedre cholinstatus, bedre vækst i højde, vægt, muskler og knogler, bedre lunger og forbedring af sundhedsstatus.
Undersøgelsen vil indskrive i alt 78 deltagere fra Children's Hospital of Philadelphia (CHOP) og fra flere andre Cystisk Fibrose-centre. Den ene halvdel af deltagerne vil blive tilfældigt udvalgt til at modtage det aktive pulver med LYM-X-SORB™-supplementet, og den ene halvdel vil modtage en placebo (uden aktivt tilskud).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
110
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia (CHOP)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 17 år (BARN)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Diagnosticeret med cystisk fibrose (CF) med bugspytkirtelinsufficiens (PI)
- Forsøgspersoner i alderen 6 til 17 år
- I sædvanlig tilstand af godt helbred
- Familie- og emneforpligtelse til 18-måneders studieprotokollen
- Fækal elastase < 15µg/g afføring
Ekskluderingskriterier:
- Forceret ekspiratorisk volumen efter et sekund, % forudsagt (FEV1) < 40 % forudsagt
- Andre kroniske helbredstilstande, der kan påvirke GI-absorption, vækst, diætindtag, ernæringsstatus
- Leversygdom, lungetransplantation, cøliaki, allergi/intolerance over for hvede/gluten, gravid
- Deltagelse i en anden CF ernæringsrelateret interventionsundersøgelse
- Regelmæssigt indtag af fedtsyrer (dvs. fiskeolier) eller cholin kosttilskud
- Parenteral lipidadministration til hjemmet (dvs. intralipider)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: SUPPORTIVE_CARE
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: DOBBELT
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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PLACEBO_COMPARATOR: 2
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Placeboen er sammensat af sojabønneolie, solsikkeolie, fuldt hydrogeneret bomuldsfrøolie og hørfrøolie fordelt ved 16 vægt% på mel og sukker.
Placebo er >99% triglycerider uden transfedtsyrer.
Fedtsyresammensætningen og kalorieindholdet er designet til at matche det aktive supplement (Lym-X-Sorb).
En dosis indeholder 32 gram pulver og indtages sammen med mad to gange om dagen (6 til 11,9 år) eller tre gange om dagen (12 til 17,9 år) i 18 måneder.
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ACTIVE_COMPARATOR: 1
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Lym-X-Sorb er en organiseret matrix af lysophosphatidylcholin (LPC), fri fedtsyre (FFA) og monoglycerid formuleret til 20 vægt% med mel og sukker.
En dosis indeholder 32 gram pulver og indtages sammen med mad to gange om dagen (6 til 11,9 år) eller tre gange om dagen (12 til 17,9 år) i 18 måneder.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Forbedringer i essentiel fedtsyre (EFA) og cholinstatus over en 12-måneders periode.
Tidsramme: 12 måneders periode
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12 måneders periode
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Forbedringer i vækst, ernæring og lungestatus over en 18-måneders periode.
Tidsramme: 18 måneders periode
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18 måneders periode
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Walter A. Shaw, PhD, Avanti Polar Lipids, Inc.
- Ledende efterforsker: Virginia A. Stallings, MD, Children's Hospital of Philadelphia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2007
Primær færdiggørelse (FAKTISKE)
1. juni 2012
Studieafslutning (FAKTISKE)
1. juni 2012
Datoer for studieregistrering
Først indsendt
29. november 2006
Først indsendt, der opfyldte QC-kriterier
29. november 2006
Først opslået (SKØN)
4. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
14. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DK60302
- R44DK060302 (NIH)
- 2R44DK060302-02A1 (NIH)
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