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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06285799




Registration number
NCT06285799
Ethics application status
Date submitted
19/02/2024
Date registered
29/02/2024

Titles & IDs
Public title
Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women
Scientific title
A Randomised, Double-blind Study to Determine the Safety and Efficacy of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women
Secondary ID [1] 0 0
IHAT_ID_2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron-deficiency 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low Dose IHAT
Treatment: Drugs - High Dose IHAT
Treatment: Drugs - Carob Flour

Experimental: Low Dose IHAT - 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

Experimental: High Dose IHAT - 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)

Placebo comparator: Carob flour - Carob flour in capsule form - taken as 2 capsules daily with water (1 capsule in the morning and 1 capsule in the evening)


Treatment: Drugs: Low Dose IHAT
Once daily dose of 1 IHAT capsule (100mg IHAT per capsule) and once daily dose of 1 placebo capsule (carob flour)

Treatment: Drugs: High Dose IHAT
Twice daily dose of 1 IHAT capsule (100mg IHAT per capsule)

Treatment: Drugs: Carob Flour
Twice daily dose of 1 placebo capsule (carob flour)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of women recovering from iron deficiency at week 12
Timepoint [1] 0 0
week 12
Secondary outcome [1] 0 0
Time to reach normalisation of ferritin levels
Timepoint [1] 0 0
Baseline, week 6 and week 12
Secondary outcome [2] 0 0
Change in iron status
Timepoint [2] 0 0
Baseline, week 6 and week 12
Secondary outcome [3] 0 0
Change in fatigue
Timepoint [3] 0 0
Baseline, week 6 and week 12
Secondary outcome [4] 0 0
Incidence and prevalence of gastrointestinal side effects
Timepoint [4] 0 0
Baseline, week 1-6 and week 12
Secondary outcome [5] 0 0
Iron deficiency symptoms
Timepoint [5] 0 0
Baseline, week 6 and week 12

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nemysis Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
RDC Clinical Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maria Cristina Comelli, PhD
Address 0 0
Nemysis Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06285799