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

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: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Drug: Carob flour; Drug: Low dose IHAT; Drug: High Dose IHAT

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

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
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

Outcome Measure	Measure Description	Time Frame
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	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
Iron Status	Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test	Baseline, week 6 and week 12
Change in fatigue	Change in fatigue via Fatigue Severity Questionnaire	Baseline, week 6 and week 12
Iron deficiency symptoms	Iron deficiency symptoms via SF-36 Questionnaire	Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects	- Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire	Baseline, weeks 1 - 5, week 6 and week 12

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: Nemysis Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 3, 2025

Study Registration Dates

• First Submitted: June 3, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies; Gastrointestinal Agents; Antidiarrheals; Locust bean gum
• Other Study ID 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