Iron-deficiencyPhase 3NCT05950841
Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman
A Phase 3 study testing Low dose IHAT, High Dose IHAT and Carob flour in people with Iron-deficiency, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Low dose IHAT, High Dose IHAT and Carob flour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Mar 2024to 3 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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.
- 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%.
- Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
- 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.
- Chronic past and/or current alcohol use (>14 alcohol drinks/week).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Iron-deficiency
- Being tested
- Low dose IHAT, High Dose IHAT, Carob flour
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose IHATDrug
Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
High Dose IHATDrug
Twice daily dose of 1 capsule (100mg per capsule IHAT)
Carob flourDrug
Twice daily dose of 1 capsule (carob flour)
| Study group | Role | What they receive |
|---|---|---|
| Low dose IHAT | Experimental | 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 Receives: Drug: Low dose IHAT |
| High dose IHAT | Experimental | IHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening) Receives: Drug: High Dose IHAT |
| Carob flour | Placebo comparator | Carob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening) Receives: Drug: Carob flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women recovering from ID at week 12
Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 30 -150 ug/L
Measured: Week 12
Secondary outcomes (5)
Time to reach normalisation of ferritin levels
Time to reach normalisation of ferritin levels via blood test results
Measured: Baseline, week 6 and week 12
Iron Status
Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test
Measured: Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects
- Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire
Measured: Baseline, weeks 1 - 5, week 6 and week 12
Change in fatigue
Change in fatigue via Fatigue Severity Questionnaire
Measured: Baseline, week 6 and week 12
Iron deficiency symptoms
Iron deficiency symptoms via SF-36 Questionnaire
Measured: Baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start6 Mar 2024
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nemysis Ltd
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950841
- Sponsor's protocol ID
- IHATID
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.
- ClinicalTrials.gov ID
- NCT05950841
- Acronym / sponsor ID
- IHATID
- Conditions
- Iron-deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Nemysis Ltd
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose IHAT | Experimental | Drug: Low dose IHATIHAT 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 |
| High dose IHAT | Experimental | Drug: High Dose IHATIHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening) |
| Carob flour | Placebo comparator | Drug: Carob flourCarob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose IHATOnce daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour) | Drug | Low dose IHAT |
| High Dose IHATTwice daily dose of 1 capsule (100mg per capsule IHAT) | Drug | High dose IHAT |
| Carob flourTwice daily dose of 1 capsule (carob flour) | Drug | Carob flour |
Primary outcome
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
5 secondary outcomes
Time to reach normalisation of ferritin levels
Time frame: Baseline, week 6 and week 12
Iron Status
Time frame: Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects
Time frame: Baseline, weeks 1 - 5, week 6 and week 12
Change in fatigue
Time frame: Baseline, week 6 and week 12
Iron deficiency symptoms
Time frame: Baseline, week 6 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose IHAT, High Dose IHAT and Carob flour in people with Iron-deficiency, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women recovering from ID at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.