- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02779465
Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma (VDHCC)
19. maj 2016 opdateret af: Yutian Chong, Third Affiliated Hospital, Sun Yat-Sen University
Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B
The purpose of this study is to determine whether vitamin D is effective in the prevention of hepatocellular carcinoma in those patients with chronic hepatitis B.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Potential participants will be identified from the follow-up cohort of chronic hepatitis B in the third Affiliated Hospital of Sun Yat-sen University (3rd SYSU).
The hepatologists at the 3rd SYSU's Infectious Disease Institute will ask each potential participant if she/he is interested in participating.
If the patient expresses an interest in the study, one of the researchers will meet with the patient when he/she is at the 3rd SYSU for a regular appointment and will describe the study to the potential participant.
If a patient continues to be interested in participating, she/he will be given a copy of the review board approved consent document to read.
The consent document will be used as a guide for explaining the study in detail to the patient.
The participant allocated to the experimental group will be contacted by one of the investigators on the research team and instructed to begin taking 2 tablets per day (800 IU total) of vitamin D3 besides their regular anti-virus treatment.
Those patients allocated in the control group will be informed that they are not to take any vitamin D3 and they will be followed as controls for this study.
The researcher will investigate general treatment benefits and the potential to reduce the development of Hepatocellular carcinoma (HCC), also known as liver cancer.
Improvement of treatment benefits will be determined by interviews with patients, the level of HBsAg and HBeAg, the development of liver fibrosis and evidence of HCC on routine imaging.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
1500
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yutian Chong, MD
- E-mail: ytchongkyzy@126.com
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
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All subjects between the ages of 18 and 70 with chronic hepatitis B and under the oral anti-virus treatment followed at the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, will be offered entry into this study. The diagnosis of chronic Hepatitis B will be based on that they had been positive for hepatitis B surface antigen (HBsAg) for at least six months, and were positive for HBeAg or negative for HBeAg with detectable HBV DNA at screening.
- No evidence of HCC on entry imaging study.
- Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
- Not currently participating in another intervention study.
- Not pregnant or lactating, and willing to use effective contraception during study period.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Ability to provide written informed consent according to national/local regulations.
Exclusion Criteria:
- evidence of hepatocellular carcinoma within 6 months after enrollment,
- a serum alanine aminotransferase level more than 10 times the upper limit of normal,
- an elevated serum creatinine level,
- any diagnosis of kidney stones,
- a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,
- any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,
- other serious concurrent illness (e.g., alcoholism, uncontrolled diabetes, or cancer),
- treatment with immunomodulatory within the 6 months before screening,
- treatment with any investigational drug within the 30 days before the study began.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Vitamin D
Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine
|
Participants with chronic hepatitis B will take 800 IU of vitamin D3 per day by mouth besides the anti-virus treatment with nucleos(t)ide medicine
|
Ingen indgriben: Control
chronic hepatitis B patients with long term anti-virus therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in serum levels of 25-hydroxy vitamin D
Tidsramme: at baseline, and at 6 and 12 months
|
Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline
|
at baseline, and at 6 and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in serum creatinine
Tidsramme: at baseline, and at 6 and 12 months
|
Change in serum creatinine at 6 months and at 12 months compared to baseline
|
at baseline, and at 6 and 12 months
|
Change in fibrosis score
Tidsramme: at baseline, and at 6 and 12 months
|
Change in fibrosis score at 6 months and at 12 months compared to baseline.
The investigators use Fibroscan to get the score of fibrosis.
|
at baseline, and at 6 and 12 months
|
Number of participants on Vitamin D treatment with adverse events
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yutian Chong, MD, Third Affiliated Hospital, Sun Yat-Sen University
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.
Generelle publikationer
- Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.
- Dalhoff K, Dancey J, Astrup L, Skovsgaard T, Hamberg KJ, Lofts FJ, Rosmorduc O, Erlinger S, Bach Hansen J, Steward WP, Skov T, Burcharth F, Evans TR. A phase II study of the vitamin D analogue Seocalcitol in patients with inoperable hepatocellular carcinoma. Br J Cancer. 2003 Jul 21;89(2):252-7. doi: 10.1038/sj.bjc.6601104.
- Ding EL, Mehta S, Fawzi WW, Giovannucci EL. Interaction of estrogen therapy with calcium and vitamin D supplementation on colorectal cancer risk: reanalysis of Women's Health Initiative randomized trial. Int J Cancer. 2008 Apr 15;122(8):1690-4. doi: 10.1002/ijc.23311.
- Krishnan AV, Feldman D. Mechanisms of the anti-cancer and anti-inflammatory actions of vitamin D. Annu Rev Pharmacol Toxicol. 2011;51:311-36. doi: 10.1146/annurev-pharmtox-010510-100611.
- Woo TC, Choo R, Jamieson M, Chander S, Vieth R. Pilot study: potential role of vitamin D (Cholecalciferol) in patients with PSA relapse after definitive therapy. Nutr Cancer. 2005;51(1):32-6. doi: 10.1207/s15327914nc5101_5.
- Amir E, Simmons CE, Freedman OC, Dranitsaris G, Cole DE, Vieth R, Ooi WS, Clemons M. A phase 2 trial exploring the effects of high-dose (10,000 IU/day) vitamin D(3) in breast cancer patients with bone metastases. Cancer. 2010 Jan 15;116(2):284-91. doi: 10.1002/cncr.24749.
- Sherman MH, Yu RT, Engle DD, Ding N, Atkins AR, Tiriac H, Collisson EA, Connor F, Van Dyke T, Kozlov S, Martin P, Tseng TW, Dawson DW, Donahue TR, Masamune A, Shimosegawa T, Apte MV, Wilson JS, Ng B, Lau SL, Gunton JE, Wahl GM, Hunter T, Drebin JA, O'Dwyer PJ, Liddle C, Tuveson DA, Downes M, Evans RM. Vitamin D receptor-mediated stromal reprogramming suppresses pancreatitis and enhances pancreatic cancer therapy. Cell. 2014 Sep 25;159(1):80-93. doi: 10.1016/j.cell.2014.08.007.
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. juni 2016
Primær færdiggørelse (Forventet)
1. juni 2016
Studieafslutning (Forventet)
1. december 2026
Datoer for studieregistrering
Først indsendt
13. maj 2016
Først indsendt, der opfyldte QC-kriterier
19. maj 2016
Først opslået (Skøn)
20. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Hepatitis, viral, menneskelig
- Hepadnaviridae infektioner
- DNA-virusinfektioner
- Neoplasmer i leveren
- Enterovirus infektioner
- Picornaviridae infektioner
- Karcinom
- Hepatitis B
- Hepatitis
- Carcinom, hepatocellulært
- Hepatitis A
- Lægemidlers fysiologiske virkninger
- Mikronæringsstoffer
- Vitaminer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- D-vitamin
- Cholecalciferol
Andre undersøgelses-id-numre
- SYSU-CYT-VD5010
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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 .
Kliniske forsøg med Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesIkke rekrutterer endnu
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu... og andre samarbejdspartnereRekrutteringKronisk hepatitis b | Reaktivering af hepatitis BTaiwan
-
Mahidol UniversityUkendtKronisk Hepatitis B, HBsAg, Hepatitis B-vaccineThailand
-
Tongji HospitalGilead SciencesRekruttering
-
Jiangsu HengRui Medicine Co., Ltd.Ukendt
-
Changhai HospitalAfsluttet
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtKronisk hepatitis b
-
Brii Biosciences LimitedVir Biotechnology, Inc.Aktiv, ikke rekrutterendeKronisk hepatitis B-virusinfektionSingapore, Thailand, Australien, Kina, Korea, Republikken
-
Nanfang Hospital of Southern Medical UniversityRekruttering
-
IlDong Pharmaceutical Co LtdRekrutteringKronisk hepatitis bKorea, Republikken
Kliniske forsøg med Vitamin D3
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Aktiv, ikke rekrutterende
-
Medical University of South CarolinaThrasher Research FundAfsluttetD-vitamin mangel | GraviditetForenede Stater
-
Aga Khan UniversityAfsluttet
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National... og andre samarbejdspartnereAfsluttetHIV-infektionForenede Stater, Puerto Rico
-
Rutgers UniversityAfsluttet
-
Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun...AfsluttetD-vitamin mangel | GraviditetMongoliet
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkAfsluttetMigræne ifølge International Headache Society (IHS) kriterier (ICHD-II)Danmark
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttet
-
National Institute of Allergy and Infectious Diseases...Autoimmunity Centers of ExcellenceAfsluttetSystemisk lupus erythematosusForenede Stater
-
University of California, San FranciscoAfsluttetColitis ulcerosa (UC) | Crohns sygdom (CD)Forenede Stater