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

NCT05950841 | Completed Phase 3

• 1 other identifier: IHATID
• 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 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.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to reach normalisation of ferritin levels

  Baseline, week 6 and week 12

• Iron Status

  Baseline, week 6 and week 12

• Incidence and prevalence of gastrointestinal side effects

  Baseline, weeks 1 - 5, week 6 and week 12

• Change in fatigue

  Baseline, week 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 (equiv 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 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening)

Drug: High Dose IHAT

Carob flour

PLACEBO COMPARATOR

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

Interventions

Low dose IHAT DRUG

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

Low dose IHAT

High Dose IHAT DRUG

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

High dose IHAT

Carob flour DRUG

Twice daily dose of 1 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 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

You may not qualify if:

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

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

Study Sites (1)

RDC Clinical Pty Ltd

New Farm, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

locust bean gum

Condition Hierarchy (Ancestors)

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

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

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: June 3, 2023
• First Posted: July 18, 2023
• Study Start: March 6, 2024
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)