RecruitingACTRN12622000143729

Venesection in iron overload and concurrent non-alcoholic fatty liver disease

Assessing the efficacy and safety of venesection in patients with dysmetabolic iron overload syndrome and non-alcoholic fatty liver disease


Sponsor

Marie Sinclair

Enrollment

15 participants

Start Date

Sep 29, 2021

Study Type

Interventional

Conditions

Summary

This study is assessing the utility of regular venesection (blood removal) for treatment of patients with non-alcoholic fatty liver disease and concurrent iron-overload on liver biopsy. Patients involved in this study will undergo 4-weekly venesection for up to 10-months, with a liver biopsy prior to and after the venesection schedule to assess the impact on non-alcoholic fatty liver disease and liver iron overload. We hypothesise that regular venesection will be a tolerable therapy that improves iron overload on liver biopsy and reduces severity of non-alcoholic fatty liver disease on liver biopsy.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Non-alcoholic fatty liver disease (NAFLD) is a condition where excess fat builds up in the liver, and it affects a large and growing proportion of the population — particularly those with obesity, diabetes, or metabolic syndrome. When iron also accumulates in the liver alongside the fat, the combination may accelerate liver damage. Venesection (therapeutic blood removal, like donating blood) is already used to reduce iron overload in conditions like haemochromatosis — but its potential role in treating NAFLD with concurrent iron overload has not been properly studied. This study will enrol patients with confirmed NAFLD and high liver iron on biopsy, and ask them to undergo venesection (blood removal) every four weeks for up to 10 months. A liver biopsy will be performed before and after to directly measure changes in both fat and iron content in the liver. You may be eligible if you are aged 18–70, have NAFLD confirmed by imaging or biopsy, have a serum ferritin above 600, and have iron overload confirmed on a liver biopsy. People who are anaemic, have hereditary haemochromatosis, drink excessively, have heart failure, or have advanced liver cirrhosis are not eligible. This is an important and practical study — venesection is a simple, low-cost therapy that, if proven effective, could help a large number of people with a condition for which effective treatments remain limited.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will undergo 4-weekly venesection of 1 unit (400-500mL) of blood in the outpatient pathology centre, with experienced nursing staff performing venipuncture. Each venesection takes between 15-

Patients will undergo 4-weekly venesection of 1 unit (400-500mL) of blood in the outpatient pathology centre, with experienced nursing staff performing venipuncture. Each venesection takes between 15-30 minutes. Up to a maximum of 10 venesections will be performed, with patients not undergoing their next scheduled venesection if they develop anaemia (Hb <120 g/L for women, Hb <130 g/L for men) or de-iron to a serum ferritin <200 micrograms/L. Patients who achieve a serum ferritin <200 micrograms/L prior to 10 venesections will remain in the study and continue to have 4-weekly blood tests, recommencing venesection if ferritin rises above 200 micrograms/L within 8 weeks of last venesection and if within 10 months of first venesection. The maximum total duration of the intervention is 12 months. Adherence to venesection will be monitored through view of planned blood tests on the same day as scheduled venesection. All patients will be provided with identical dietary advice and exercise advice for non-alcoholic fatty liver disease as per standard of care (this will be recommendations to reduce simple carbohydrates and saturated fats, with advice to follow the Mediterranean diet; and recommendation to undergo 30 minutes of exercise of at least moderate intensity 4-5 days per week). This advice will be provided verbally.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12622000143729