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Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women

PHASE3RECRUITING

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Study details:

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. IHAT is a novel bioavailable source of iron. It is a tartrate-modified, nanoparticulate ferric oxo-hydroxide with similar functional properties and small primary particle size to the iron form found in the ferritin core (ferrihydrite).

In this trial, subjects will be randomly assigned to receive either (1) IHAT once a day, (2) IHAT twice a day or (3) a placebo daily for 12 weeks. The primary endpoint is the correction of iron deficiency at week 12. Secondary endpoints include iron status, iron deficiency symptoms and gastrointestinal symptoms over the course of the 12 weeks.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2024-03-05

Primary completion: 2025-12-01

Study completion finish: 2025-12-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06285799

Intervention or treatment

DRUG: Low Dose IHAT

DRUG: High Dose IHAT

DRUG: Carob Flour

Conditions

• Iron-deficiency

Condition: Iron-deficiency
DRUG: Low Dose IHAT and other drugs
Brisbane, Queensland, Australia
Sponsor: Nemysis Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

RDC Clinical Pty Ltd

Research sites nearby

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RDC Clinical Pty Ltd
Brisbane, Queensland, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Low Dose IHAT IHAT in capsule form and carob flour in capsule form - taken as 1 x 100mg IHAT capsule (equivalent to 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 IHAT capsule (100mg IHAT per capsule) and once daily dose of 1 placebo capsule (carob flour)
EXPERIMENTAL: High Dose IHAT IHAT in capsule form - taken as 2 capsules (2 x 100mg IHAT, equivalent to 60mg iron total) daily with water (1 capsule in the morning and 1 capsule in the evening)	DRUG: High Dose IHAT Twice daily dose of 1 IHAT capsule (100mg IHAT per capsule)
PLACEBO_COMPARATOR: Carob flour Carob flour in capsule form - taken as 2 capsules daily with water (1 capsule in the morning and 1 capsule in the evening)	DRUG: Carob Flour Twice daily dose of 1 placebo capsule (carob flour)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percentage of women recovering from iron deficiency at week 12	Percentage of women recovering from iron deficiency at week 12, defined as serum ferritin levels of 30 - 150 ug/L	week 12

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to reach normalisation of ferritin levels	Time to reach normalisation of ferritin levels via blood test results	Baseline, week 6 and week 12
Change in iron status	Iron status assessed by serum ferritin in ug/L, haemoglobin in g/dL, serum iron in uM and transferrin saturation, defined as serum iron divided by total iron binding capacity and expressed as a percentage	Baseline, week 6 and week 12
Change in fatigue	Change in fatigue via Fatigue Severity Scale	Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects	Incidence and prevalence of gastrointestinal side effects via gastrointestinal symptom questionnaire	Baseline, week 1-6 and week 12
Iron deficiency symptoms	Iron deficiency symptoms via 36-Item Short Form Survey Instrument (SF-36)	Baseline, week 6 and week 12

Frequently Asked Questions

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References

Clinical Trials Gov: Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women