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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05950841
Other study ID # IHATID
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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