Iron-deficiency
Conditions
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 iron-deficient but otherwise healthy premenopausal women over 12 weeks.
Interventions
DRUGLow dose IHAT
Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
DRUGHigh Dose IHAT
Twice daily dose of 1 capsule (100mg per capsule IHAT)
DRUGCarob flour
Twice daily dose of 1 capsule (carob flour)
Sponsors
Nemysis Ltd
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 30 -150 ug/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach normalisation of ferritin levels | Baseline, week 6 and week 12 | Time to reach normalisation of ferritin levels via blood test results |
| 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 | Baseline, weeks 1 - 5, 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 |
Countries
Australia
Outcome results
None listed