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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Once daily dose of 1 capsule (100mg per capsule IHAT) and Once daily dose of 1 capsule (carob flour)
Twice daily dose of 1 capsule (100mg per capsule IHAT)
Twice daily dose of 1 capsule (carob flour)
RDC Clinical Pty Ltd
New Farm, Queensland, Australia
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
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
Iron Status
Iron Status (Serum ferritin, Hb levels, Serum iron levels, TSAT levels, NTBI) via blood test
Time frame: Baseline, week 6 and week 12
Incidence and prevalence of gastrointestinal side effects
\- Incidence and prevalence of gastrointestinal side effects via Gastrointestinal questionnaire
Time frame: Baseline, weeks 1 - 5, week 6 and week 12
Change in fatigue
Change in fatigue via Fatigue Severity Questionnaire
Time frame: Baseline, week 6 and week 12
Iron deficiency symptoms
Iron deficiency symptoms via SF-36 Questionnaire
Time frame: Baseline, week 6 and week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.