Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

What this trial studies

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.

Conditions in scope

• Iron-deficiency

Interventions

• Low dose IHAT (Drug) — Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
• High Dose IHAT (Drug) — Twice daily dose of 1 capsule (100mg per capsule IHAT)
• Carob flour (Drug) — Twice daily dose of 1 capsule (carob flour)

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

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

Exclusion criteria

• Anaemia (as determined from the haematocrit and haemoglobin measures) (2)
• Previously told they have an iron absorption problem
• 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)
• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2024-03-06
• Primary completion: 2025-02-03
• Last update posted: 2025-03-10
• First posted: 2023-07-18

Sponsor & contact

Lead sponsor: RDC Clinical Pty Ltd (Industry)

Collaborators: Nemysis Ltd

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Percentage of women recovering from ID at week 12 (Week 12)
  Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 30 -150 ug/L

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.