RecruitingPhase 2ACTRN12622000412730

IV iron infusion therapy in patients with persistent pain

The efficacy of IntraVenous Iron Therapy in persistent pAin patients with iron deficiency: a randomised controLled trial: The VITAL Trial.


Sponsor

Metro North Health Services Royal Brisbane and Women's Hospital

Enrollment

160 participants

Start Date

Aug 25, 2023

Study Type

Interventional

Conditions

Summary

Patients with persistent or chronic pain often have underlying chronic conditions that can be overlooked such as anaemia, which can have significant effect on the quality of life of patients. A recent pilot study involving patients who have persistent pain for greater than 12 months have shown that 59% have iron deficiency. This study will follow on from the pilot study to examine if intravenous iron infusions do improve this cohort of patients fatigue levels, their health-related quality of life, pain levels and reduce pain medication use. This study will be conducted at a Quaternary hospital in Brisbane as a single-site, single-blinded, parallel-group randomised controlled trial. We plan to recruit 160 participants who will be randomised to receive either intravenous iron infusion or placebo. The outcomes will be measured using specific validated surveys and questionnaires related to fatigue (FACIT), health-related quality of life (SF-36) and pain (ePPOC).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic pain — pain that persists for more than 3 months — affects millions of people and is one of the leading causes of disability. What is less commonly recognised is that iron deficiency is very common in people with chronic pain, occurring in nearly 60% of patients in a recent pilot study. Iron deficiency causes fatigue and may worsen pain sensitivity, but it often goes undetected and untreated in pain clinic patients. This Brisbane study will test whether treating iron deficiency with an intravenous (IV) iron infusion improves fatigue, quality of life, and pain levels in people with chronic pain who are iron deficient. Half of participants will receive IV iron and half will receive a saline placebo infusion, and outcomes will be measured using validated questionnaires over several months. You may be eligible if you are 18 or older, have had pain lasting more than 12 months, and have confirmed iron deficiency (low ferritin levels) with or without anaemia. People with blood disorders, pregnancy, active iron supplementation, recent surgery, or who are unable to give informed consent are not eligible.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Patients will be booked into the surgical day care unit (SDCU) at the RBWH or the Tess Cramond Pain and Research Centre at their earliest convenience for the interventional phase of the study. The stu

Patients will be booked into the surgical day care unit (SDCU) at the RBWH or the Tess Cramond Pain and Research Centre at their earliest convenience for the interventional phase of the study. The study drug will be prepared and administered by unblinded study personnel. The intervention consists of a single dose of intravenous ferric derisomaltose 20mg/kg in 100mL normal saline over 30 minutes up to a maximum dose of 1500mg. Clinical monitoring will be conducted in accordance with institutional policies for the delivery of either the interventional arm (IV Iron) or placebo (saline) depending on randomisation allocation.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000412730


Related Trials