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

Study Overview
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Brief Summary
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This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in otherwise healthy premenopausal women over 12 weeks.

Official Title
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A Randomised, Double-blind Study to Determine the Safety and Efficacy of IHAT in Iron Deficient Premenopausal Women.

Conditions
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Iron-deficiency

Intervention / Treatment
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* Drug: Low dose IHAT
* Drug: High Dose IHAT
* Drug: Carob flour


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose IHAT<br>IHAT in capsule form and carob flour in capsule form - taken as 1 x 100mg IHAT capsule (equiv 30mg iron) in the morning with water and 1 x placebo capsule in the evening with water | Drug: Low dose IHAT<br>* Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)<br>|
| Experimental: High dose IHAT<br>IHAT in capsule form - taken as 2 x 100mg (equiv 60mg iron) daily with water (1 in the morning and 1 in the evening) | Drug: High Dose IHAT<br>* Twice daily dose of 1 capsule (100mg per capsule IHAT)<br>|
| Placebo Comparator: Carob flour<br>Carob flour in capsule form - taken as 2 x capsules daily with water (1 in the morning and 1 in the evening) | Drug: Carob flour<br>* Twice daily dose of 1 capsule (carob flour)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women recovering from ID at week 12 | Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 30 -150 ug/L | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach normalisation of ferritin levels | Time to reach normalisation of ferritin levels via blood test results | Baseline, week 6 and week 12 | 
| Hb increase of at least 1 g/dL from baseline in those women who presented with Iron Deficiency Anaemia at baseline | Hb increase of at least 1 g/dL from baseline in those women who presented with Iron Deficiency Anaemia at baseline via blood test | Baseline, week 6 and week 12 | 
| Iron Status | Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test | Baseline, week 6 and week 12 | 
| Incidence and prevalence of gastrointestinal side effects | - Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire | Baseline, weeks 1 - 5, week 6 and week 12 | 
| Change in fatigue | Change in fatigue via Fatigue Severity Questionnaire | Baseline, week 6 and week 12 | 
| Iron deficiency symptoms | Iron deficiency symptoms via SF-36 Questionnaire | Baseline, week 6 and week 12 |