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

March 6, 2025 updated by: RDC Clinical Pty Ltd

A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • New Farm, Queensland, Australia, 4006
        • RDC Clinical Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • 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 the 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Carob flour
Carob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening)
Drug: Carob flour
Twice daily dose of 1 capsule (carob flour)
Experimental: Low dose IHAT
IHAT in capsule form and carob flour in capsule form - taken as 1 x 100mg IHAT capsule (equiv 30mg iron) in the morning with water and 1 x placebo capsule in the evening with water
Drug: Low dose IHAT
Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
Experimental: High dose IHAT
IHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening)
Drug: High Dose IHAT
Twice daily dose of 1 capsule (100mg per capsule IHAT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of women recovering from ID at week 12
Time Frame: Week 12
Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 30 -150 ug/L
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to reach normalisation of ferritin levels
Time Frame: Baseline, week 6 and week 12
Time to reach normalisation of ferritin levels via blood test results
Baseline, week 6 and week 12
Iron Status
Time Frame: Baseline, week 6 and week 12
Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test
Baseline, week 6 and week 12
Change in fatigue
Time Frame: Baseline, week 6 and week 12
Change in fatigue via Fatigue Severity Questionnaire
Baseline, week 6 and week 12
Iron deficiency symptoms
Time Frame: Baseline, week 6 and week 12
Iron deficiency symptoms via SF-36 Questionnaire
Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects
Time Frame: Baseline, weeks 1 - 5, week 6 and week 12
- Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire
Baseline, weeks 1 - 5, week 6 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RDC Clinical Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nemysis Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IHATID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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