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

Inclusion Criteria:

• Generally healthy iron deficient premenopausal women, with iron deficiency definedas 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 dietare allowed to participate) and/or exercise frequency or intensity

Exclusion Criteria:

• Anaemia (as determined from the haematocrit and haemoglobin measures) (2)

• Subjects regularly taking iron specific supplements during or 2 months prior tostudy commencement (the use of other mineral/vitamin/herbal preparations is allowedbut 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 otheranticoagulation therapy

• active smokers, nicotine use, alcohol (5) or drug (prescription or illegalsubstances) 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 participantunsuitable 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 haveserum ferritin and CRP within the required limits to be considered enrolled in thestudy 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 theirexclusion 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 astable dose of medication or is fluctuating in severity. A serious illness is acondition that carries a risk of mortality, negatively impacts quality of life anddaily function and/or is burdensome in symptoms and/ or treatments.

5. Chronic past and/or current alcohol use (>14 alcohol drinks/week).