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

NCT06285799 | Completed Phase 3

• 1 other identifier: IHAT_ID_2024
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron-deficiency

Keywords

Iron deficiency; Iron hydroxide adipate tartrate (IHAT); Iron supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to reach normalisation of ferritin levels

  Baseline, week 6 and week 12

• Change in iron status

  Baseline, week 6 and week 12

• Change in fatigue

  Baseline, week 6 and week 12

• Incidence and prevalence of gastrointestinal side effects

  Baseline, week 1-6 and week 12

• Iron deficiency symptoms

  Baseline, week 6 and week 12

Study Arms (3)

Low Dose IHAT

EXPERIMENTAL

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

High Dose IHAT

EXPERIMENTAL

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

Carob flour

PLACEBO COMPARATOR

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

Interventions

Low Dose IHAT DRUG

Once daily dose of 1 IHAT capsule (100mg IHAT per capsule) and once daily dose of 1 placebo capsule (carob flour)

Low Dose IHAT

High Dose IHAT DRUG

Twice daily dose of 1 IHAT capsule (100mg IHAT per capsule)

High Dose IHAT

Carob Flour DRUG

Twice daily dose of 1 placebo capsule (carob flour)

Carob flour

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participants who have participated in any other clinical trial during 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.

Sponsors & Collaborators

• Nemysis Ltd: lead
• RDC Clinical Pty Ltd: collaborator

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

locust bean gum

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maria Cristina Comelli, PhD

  Nemysis Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 29, 2024
• Study Start: March 5, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 15, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)