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

A Randomised, Double-blind Study to Determine the Safety and Efficacy of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Iron-deficiency
• Intervention / Treatment: Drug: Low Dose IHAT; Drug: High Dose IHAT; Drug: Carob Flour

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
• Study Contact Backup: Name: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Recruiting
      • RDC Clinical Pty Ltd
      • Contact: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
      • Contact: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au
      • Principal Investigator: Amanda Rao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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 Measures

Outcome Measure	Measure Description	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 Measures

Outcome Measure	Measure Description	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

Collaborators and Investigators

• Sponsor: Nemysis Ltd
• Collaborators: RDC Clinical Pty Ltd
• Investigators: Study Director: Maria Cristina Comelli, PhD, Nemysis Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Iron supplementation; Iron deficiency; Iron hydroxide adipate tartrate (IHAT)
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Iron Deficiencies; Gastrointestinal Agents; Antidiarrheals; Locust bean gum
• Other Study ID Numbers: IHAT_ID_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No