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

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).