This is a 12 week study looking to assess the effectiveness of a new iron treatment called IHAT for treating iron deficiency.
Traditional iron therapies have been known to cause side effects as high doses are often required to achieve sufficient absorption. Based on this, a novel therapy has been developed called iron hydroxide adipate tartrate (IHAT). IHAT is a nanoparticle formulation containing iron hydroxide, tartaric acid, and adipic acid and resembles the normal metabolite ferritin.

To determine your suitability for this study, we will first ask you some screening questions over the phone today. If it looks like you are a match for the study, the 2nd part of the screening involves a blood test to check if your iron levels, and CRP (which is an inflammatory marker) is within the allowable range for this study. We'll send you a referral to an ACL Pathology Clinic for this after your screening call, and once we've reviewed your results, you'll have a telehealth phone appointment with our trial doctor.
During this call, the doctor complete the final part of screening by asking a few further questions about your general health.

If you are found to be eligible to participate, you will be randomly assigned to one of 3 study groups.
The first group will receive a 30mg dose of the study product
The second group will receive a 60mg dose of the study product
And the third group will receive a placebo product, with no active ingredients.
Neither you nor your Trial Coordinator will know which group you have been placed in until the end of the study.

This study is being conducted remotely. As such, there are no face-to-face appointments required. We will conduct phone appointments with you at Baseline, week 3, 6, 9 and again after 12 weeks and there are some questionnaires that we will email out to you at Baseline, 6 and 12 weeks. You'll also be required to complete further blood tests at week 6 and week 12, and your Trial Coordinator will check in with you regularly throughout the study.

If you do complete the study, you will receive a $150 payment as a thank you for taking part.

Thank you for your time on the phone. We will now email you out a digital consent form for you to read and sign.
Once you have returned this to us, we will then send you a referral form so you can attend your local ACL pathology clinic for your blood test to check your current iron levels.
If you do not have low iron...that's great news, but you will not be able to participate in this study. If you do have low iron, our trial doctor will give you a quick call for a brief telehealth consultation to discuss the results with you and complete the final part of screening.

Thank you so much for your time on the phone today. Please keep an eye out for our email. Do you have any other questions?