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

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

• 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.
• 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%.
• Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
• 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.
• Chronic past and/or current alcohol use (>14 alcohol drinks/week).