- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02098317
DHA and Vitamin D in Children With Biopsy-proven NAFLD (VitD_DHA)
Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression.
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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-
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Rome, Italia, 00165
- Bambino Gesu Children Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- biopsy consistent with the diagnosis of NAFLD/NASH
- reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- International normalized ratio (INR) < 1,3
- Albumin > 3 g/dl
- total bilirubin < 2,5 mg/dl
- no previous gastrointestinal bleeding
- no previous portosystemic encephalopathy
- normal renal function
- no hepatitis B, hepatitis C infection
- normal cell blood count
Exclusion Criteria:
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: TREATED GROUP
this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks
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DHA 500 mg plus Vitamin D 800 IU
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Placebo komparator: PLACEBO GROUP
this group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks
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Placebo pearls mimicking pearls with DHA and Vitamin D
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Forbedring i NAFLD Activity Score (NAS)
Tidsramme: 12 måneder
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12 måneder
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
Tidsramme: at 6 and 12 months
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at 6 and 12 months
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safety
Tidsramme: 6 months
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clinical examination, medical history and specific laboratory parameters
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6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Valerio Nobili, Professor, Bambino Gesu Children Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VD3_DHA_NAFLD
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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-
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