Studie LYM-X-SORB™ ke zlepšení stavu mastných kyselin a cholinu u dětí s CF a PI
11. ledna 2013 aktualizováno: Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.
Studie fáze II: LYM-X-SORB™, organizovaná lipidová matrice: mastné kyseliny a cholin v CF
Účelem této výzkumné studie fáze II je vyhodnotit účinnost nové generace LYM-X-SORB™ při zlepšování stavu esenciálních mastných kyselin (EFA) a cholinu u dětí a dospívajících s cystickou fibrózou (CF) a pankreatickou insuficiencí (PI). ).
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
Malabsorpce tuku je běžná u jedinců s cystickou fibrózou (CF) a pankreatickou insuficiencí (PI). To je vystavuje riziku nedostatku kalorií, esenciálních mastných kyselin a cholinu, což může následně vést k selhání růstu a horšímu klinickému průběhu. Účelem této výzkumné studie je zjistit, zda užívání LYM-X-SORB™ po dobu 18 měsíců každý den napraví problém, který mají lidé s CF a PI se vstřebáváním tuku a cholinu. Účast pomůže lékařům s CF a dalším zdravotnickým pracovníkům dozvědět se více o potenciálních přínosech LYM-X-SORB™ pro děti a dospívající s CF a PI. Tyto výhody mohou zahrnovat lepší vstřebávání tuku, lepší stav cholinu, lepší růst do výšky, hmotnosti, svalů a kostí, lepší plíce a zlepšení zdravotního stavu.
Do studie se zapojí celkem 78 účastníků z dětské nemocnice ve Filadelfii (CHOP) az několika dalších center cystické fibrózy. Jedna polovina účastníků bude náhodně vybrána, aby dostali aktivní prášek s doplňkem LYM-X-SORB™ a jedna polovina obdrží placebo (bez aktivního doplňku).
Typ studie
Intervenční
Zápis (Aktuální)
110
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Children's Hospital of Philadelphia (CHOP)
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
6 let až 17 let (DÍTĚ)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Kritéria pro zařazení:
- Diagnostikována jako cystická fibróza (CF) s pankreatickou insuficiencí (PI)
- Subjekty ve věku 6 až 17 let
- V obvyklém dobrém zdravotním stavu
- Závazek rodiny a subjektu k 18měsíčnímu studijnímu protokolu
- Fekální elastáza < 15 µg/g stolice
Kritéria vyloučení:
- Objem usilovného výdechu za jednu sekundu, předpokládané % (FEV1) < 40 % předpokládané hodnoty
- Jiné chronické zdravotní stavy, které mohou ovlivnit vstřebávání GI, růst, příjem ve stravě, nutriční stav
- Onemocnění jater, transplantace plic, celiakie, alergie/nesnášenlivost na pšenici/lepek, těhotná
- Účast v další intervenční studii související s výživou CF
- Pravidelný příjem mastných kyselin (tj. rybích olejů) nebo cholinových doplňků výživy
- Domácí parenterální podávání lipidů (tj. intralipidů)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: SUPPORTIVE_CARE
- Přidělení: RANDOMIZOVANÝ
- Intervenční model: PARALELNÍ
- Maskování: DVOJNÁSOBEK
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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PLACEBO_COMPARATOR: 2
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Placebo se skládá ze sojového oleje, slunečnicového oleje, plně hydrogenovaného bavlníkového oleje a lněného oleje dispergovaného na 16 % hmotn. v mouce a cukru.
Placebem jsou > 99 % triglyceridů bez trans mastných kyselin.
Složení mastných kyselin a kalorický obsah jsou navrženy tak, aby odpovídaly aktivnímu doplňku (Lym-X-Sorb).
Dávka obsahuje 32 gramů prášku a užívá se s jídlem dvakrát denně (6 až 11,9 let) nebo třikrát denně (12 až 17,9 let) po dobu 18 měsíců.
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ACTIVE_COMPARATOR: 1
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Lym-X-Sorb je organizovaná matrice lysofosfatidylcholinu (LPC), volné mastné kyseliny (FFA) a monoglyceridu formulovaná na 20 % hmotn. s moukou a cukrem.
Dávka obsahuje 32 gramů prášku a užívá se s jídlem dvakrát denně (6 až 11,9 let) nebo třikrát denně (12 až 17,9 let) po dobu 18 měsíců.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Zlepšení stavu esenciálních mastných kyselin (EFA) a cholinu po dobu 12 měsíců.
Časové okno: 12měsíční období
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12měsíční období
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Zlepšení růstu, výživy a stavu plic po dobu 18 měsíců.
Časové okno: 18měsíční lhůta
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18měsíční lhůta
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Walter A. Shaw, PhD, Avanti Polar Lipids, Inc.
- Vrchní vyšetřovatel: Virginia A. Stallings, MD, Children's Hospital of Philadelphia
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2007
Primární dokončení (AKTUÁLNÍ)
1. června 2012
Dokončení studie (AKTUÁLNÍ)
1. června 2012
Termíny zápisu do studia
První předloženo
29. listopadu 2006
První předloženo, které splnilo kritéria kontroly kvality
29. listopadu 2006
První zveřejněno (ODHAD)
4. prosince 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (ODHAD)
14. ledna 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. ledna 2013
Naposledy ověřeno
1. ledna 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DK60302
- R44DK060302 (NIH)
- 2R44DK060302-02A1 (NIH)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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