Evaluating a new iron supplement for iron-deficient premenopausal women

A Randomised, Double-blind Study to Determine the Safety and Efficacy of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women

This study is testing a new iron supplement to see if it can help iron-deficient premenopausal women improve their iron levels and feel better over 12 weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Nemysis Ltd (Industry-sponsored)
• Locations: 1 site (Brisbane, Queensland)
• Trial ID: NCT06285799 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, randomized, placebo-controlled study designed to assess the safety and effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in increasing serum ferritin levels among iron-deficient, healthy premenopausal women over a 12-week period. Participants will be randomly assigned to receive either a low dose or high dose of IHAT, or a placebo, with the primary goal of correcting iron deficiency by the end of the study. Secondary outcomes will include evaluations of iron status, symptoms related to iron deficiency, and gastrointestinal side effects. The trial aims to provide insights into the efficacy of this novel iron formulation compared to traditional iron supplements.

Who should consider this trial

Good fit: Ideal candidates for this study are generally healthy premenopausal women with serum ferritin levels below 30 ug/L.

Not a fit: Patients with anemia or those taking iron supplements within two months prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a more effective and tolerable iron supplementation option for women suffering from iron deficiency.

How similar studies have performed: Other studies have shown promise with novel iron formulations, but this specific approach with IHAT is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

* Generally healthy iron deficient premenopausal women, with iron deficiency defined as serum ferritin \< 30 ug/L and generally healthy as C-reactive protein \< 3mg/L (1)
* Able to provide informed consent
* Agree not to participate in another clinical trial while enrolled in this trial
* Agree not to give blood donations during the study
* Agree not to change current diet (subjects adhering to a vegetarian or vegan diet are allowed to participate) and/or exercise frequency or intensity

Exclusion Criteria:

* Anaemia (as determined from the haematocrit and haemoglobin measures) (2)
* Subjects regularly taking iron specific supplements during or 2 months prior to study commencement (the use of other mineral/vitamin/herbal preparations is allowed but should be recorded) (3)
* Any uncontrolled serious illness (4)
* Previously told they have an iron absorption problem
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* active smokers, nicotine use, alcohol (5) or drug (prescription or illegal substances) abuse
* chronic gastrointestinal disorders
* Pregnant/lactating women or women trying to conceive
* Diagnosed depression or mental disorder that is uncontrolled
* Eating disorders
* BMI \> 35 kg/m2
* Allergic to any of the ingredients in active or placebo formula
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other clinical trial during past 1 month

Footnotes:

1. A blood test is required prior to enrolment into the study to receive trial product. Participants will be required to attend a local pathology collection centre and have serum ferritin and CRP within the required limits to be considered enrolled in the study and be provided with trial product.
2. Anyone considered to be anaemic will be excluded and directed to their GP. In women, anaemia is defined as any of the following: Haemoglobin \< 115 g/L, Haematocrit \< 35%.
3. Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
4. An uncontrolled illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/ or treatments.
5. Chronic past and/or current alcohol use (\>14 alcohol drinks/week).

Where this trial is running

Brisbane, Queensland

• RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Amanda Rao, PhD

Conditions Iron-deficiency; Iron deficiency; Iron hydroxide adipate tartrate; Iron supplementation