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

Iron-deficiency Clinical Trial

Official title:

A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950841
• Other study ID #: IHATID
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2023
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Iron-deficiency

Intervention

Drug:
• Low dose IHAT
Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
• High Dose IHAT
Twice daily dose of 1 capsule (100mg per capsule IHAT)
• Carob flour
Twice daily dose of 1 capsule (carob flour)

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	New Farm	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to reach normalisation of ferritin levels	Time to reach normalisation of ferritin levels via blood test results	Baseline, week 6 and week 12
Secondary	Iron Status	Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test	Baseline, week 6 and week 12
Secondary	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
Secondary	Change in fatigue	Change in fatigue via Fatigue Severity Questionnaire	Baseline, week 6 and week 12
Secondary	Iron deficiency symptoms	Iron deficiency symptoms via SF-36 Questionnaire	Baseline, week 6 and week 12