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

Launched by RDC CLINICAL PTY LTD · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment called IHAT (iron hydroxide adipate tartrate) in helping pre-menopausal women who are iron deficient. The goal is to see if taking IHAT can increase the levels of a protein called serum ferritin, which helps store iron in the body. The trial lasts for 12 weeks and includes different doses of IHAT compared to a placebo (a sugar pill that contains no active medication).

To participate, women must be generally healthy and meet certain criteria, such as having low serum ferritin levels (less than 30 ug/L) and not having any serious medical conditions. Women who are pregnant, breastfeeding, or have specific health issues, like anemia or certain gastrointestinal disorders, cannot join. Participants will need to agree not to change their diet or exercise routine and will not be allowed to donate blood during the study. If eligible, participants will receive the treatment or placebo and will be monitored by the research team throughout the trial to assess their health and response to the treatment.

Gender

FEMALE

Eligibility criteria

• 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).