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

Nemysis

Status and phase: Completed; Phase 3

Conditions: Iron-deficiency

Treatments: Drug: Low Dose IHAT; Drug: High Dose IHAT; Drug: Carob Flour

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285799

IHAT_ID_2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Low Dose IHAT

Experimental group

Description:

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

Treatment:

Drug: Low Dose IHAT

High Dose IHAT

Experimental group

Description:

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)

Treatment:

Drug: High Dose IHAT

Carob flour

Placebo Comparator group

Description:

Carob flour in capsule form - taken as 2 capsules daily with water (1 capsule in the morning and 1 capsule in the evening)

Treatment:

Drug: Carob Flour