This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks.
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. IHAT is a novel bioavailable source of iron. It is a tartrate-modified, nanoparticulate ferric oxo-hydroxide with similar functional properties and small primary particle size to the iron form found in the ferritin core (ferrihydrite). In this trial, subjects will be randomly assigned to receive either (1) IHAT once a day, (2) IHAT twice a day or (3) a placebo daily for 12 weeks. The primary endpoint is the correction of iron deficiency at week 12. Secondary endpoints include iron status, iron deficiency symptoms and gastrointestinal symptoms over the course of the 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Once daily dose of 1 IHAT capsule (100mg IHAT per capsule) and once daily dose of 1 placebo capsule (carob flour)
Twice daily dose of 1 IHAT capsule (100mg IHAT per capsule)
Twice daily dose of 1 placebo capsule (carob flour)
RDC Clinical Pty Ltd
Brisbane, Queensland, Australia
Percentage of women recovering from iron deficiency at week 12
Percentage of women recovering from iron deficiency at week 12, defined as serum ferritin levels of 30 - 150 ug/L
Time frame: week 12
Time to reach normalisation of ferritin levels
Time to reach normalisation of ferritin levels via blood test results
Time frame: Baseline, week 6 and week 12
Change in iron status
Iron status assessed by serum ferritin in ug/L, haemoglobin in g/dL, serum iron in uM and transferrin saturation, defined as serum iron divided by total iron binding capacity and expressed as a percentage
Time frame: Baseline, week 6 and week 12
Change in fatigue
Change in fatigue via Fatigue Severity Scale
Time frame: Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects
Incidence and prevalence of gastrointestinal side effects via gastrointestinal symptom questionnaire
Time frame: Baseline, week 1-6 and week 12
Iron deficiency symptoms
Iron deficiency symptoms via 36-Item Short Form Survey Instrument (SF-36)
Time frame: Baseline, week 6 and week 12
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