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NCT06250309 · ClinicalTrials.gov registry record · NA
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
A NA study of Autoimmune Hepatitis, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06250309: Recruiting NA study of Autoimmune Hepatitis, sponsored by Indiana University.
NCT06250309 is a NA study of Autoimmune Hepatitis that is actively recruiting participants, run by Indiana University. The registered enrollment target is 48 participants, below the 219-participant average among 5 other Autoimmune Hepatitis trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06250309, a NA study of Autoimmune Hepatitis, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.
Primary Outcome
Assessment from the patient only through data collection from the Promis-29 instrument. This 29 item instrument that measures various difficulties in health related quality of life in 7 domains. For this measure, a higher scores equals more of the concept being measured.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Dietary assignment
Study Locations (1)
Indiana
- IU Health University Hosptial - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What NCT06250309 shows while recruiting
NCT06250309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 219-participant average among 5 other Autoimmune Hepatitis trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Autoimmune Hepatitis appearing as the primary indexed condition, and to 1 intervention - of which Dietary assignment is the first listed.
NCT06250309 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06250309 about?
NCT06250309 is a clinical study titled "Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients". This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divi...
What is the current status of trial NCT06250309?
This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2023-10-23. Estimated completion is 2028-12-31.
What conditions does trial NCT06250309 study?
This clinical trial studies the following conditions: Autoimmune Hepatitis.
What interventions are being tested in trial NCT06250309?
The interventions under investigation include: Dietary assignment (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06250309?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06250309 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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