| NCT ID | NCT05855031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Alcoholic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 408 participants |
| Start Date | 2023-05-08 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 408 participants in total. It began in 2023-05-08 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.
Eligibility Criteria
Inclusion Criteria: * Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde * Informed written consent Exclusion Criteria: * Not speaking Danish or English * Severe liver disease (known by the participant)
Contact & Investigator
Gro Askgaard, PHD
PRINCIPAL INVESTIGATOR
Zealand University Hospital
Frequently Asked Questions
Who can join the NCT05855031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Alcoholic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05855031 currently recruiting?
Yes, NCT05855031 is actively recruiting participants. Contact the research team at pedah@regionsjaelland.dk for enrollment information.
Where is the NCT05855031 trial being conducted?
This trial is being conducted at Køge, Denmark, Roskilde, Denmark.
Who is sponsoring the NCT05855031 clinical trial?
NCT05855031 is sponsored by Zealand University Hospital. The principal investigator is Gro Askgaard, PHD at Zealand University Hospital. The trial plans to enroll 408 participants.