Safety and Effectiveness of IHAT in Iron Deficient Post-menopausal Woman
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low dose IHAT IHAT in capsule form and carob flour in capsule form - taken as 1 x 50mg IHAT capsule in the morning with water and 1 x placebo capsule in the evening with water |
Drug: Low dose IHAT
Once daily dose of 1 capsule (50mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
|
| Experimental: High dose IHAT IHAT in capsule form - taken as 2 x 50mg daily with water (1 in the morning and 1 in the evening) |
Drug: High Dose IHAT
Twice daily dose of 1 capsule (50mg per capsule IHAT)
|
| Placebo Comparator: Carob flour 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
Twice daily dose of 1 capsule (carob flour)
|
Outcome Measures
Primary Outcome Measures
- Percentage of women recovering from ID at week 12 [Week 12]
Percentage of women recovering from ID at week 12, defined as serum ferritin levels of 15 -150 ug/L, in agreement to WHO guidelines
Secondary Outcome Measures
- Time to reach normalisation of ferritin levels [Baseline, week 6 and week 12]
Time to reach normalisation of ferritin levels via blood test results
- Hb increase of at least 1 g/dL from baseline in those women who presented with Iron Deficiency Anaemia at baseline [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 via blood test
- Iron Status [Baseline, week 6 and week 12]
Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test
- Incidence and prevalence of gastrointestinal side effects [Week 6 and week 12]
- Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire
- Change in fatigue [Baseline, week 6 and week 12]
Change in fatigue via Fatigue Severity Questionnaire
- Iron deficiency symptoms [Baseline, week 6 and week 12]
Iron deficiency symptoms via SF-36 Questionnaire
Eligibility Criteria
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
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Agree not to give blood donations during the study
-
Able to provide informed consent
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Agree not to participate in another clinical trial while enrolled in this trial
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Agree not to change current diet and/or exercise frequency or intensity
Exclusion Criteria:
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Anaemia (as determined from the haematocrit and haemoglobin measures) (2)
-
Previously told they have an iron absorption problem
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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)
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Subjects consuming high vitamin C (supplement or foods) within the 48-hours prior to study commencement (4)
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Any uncontrolled serious illness (5)
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Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
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Active smokers, nicotine use, alcohol(6) or drug (prescription or illegal substances) abuse
-
Chronic gastrointestinal disorders
-
Pregnant/lactating women or women trying to conceive
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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
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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.
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The study medical practitioner will assess all pathology measures for the possibility of anaemia. 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 < 38% (these values are based on the normal reference ranges of QML pathology). If a participant attends a different pathology centre to QML, the reference values may be slightly different due differences in testing. Each pathology centre will provide their reference values for use.
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Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
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Potential participants that have taken vitamin C that would result in their exclusion can wait a 48-hour washout period prior to enrolment into the study.
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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.
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Chronic past and/or current alcohol use (>14 alcohol drinks/week).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RDC Clinical Pty Ltd | New Farm | Queensland | Australia | 4006 |
Sponsors and Collaborators
- RDC Clinical Pty Ltd
Investigators
- Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IHATID