Iron-deficiency
Conditions
Keywords
Iron Supplement, Iron Deficiency, >Your< Iron Syrup
Brief summary
The study evaluates the efficacy and safety of \>Your\< Iron Syrup, a novel iron-containing dietary supplement, in the management of dietary iron deficiency in children. The study is a randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in Slovenia, collectively enrolling 92 eligible children. Eligibility of children for participation in the study will be determined by screening for hemoglobin and ferritin (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children will receive basic dietary advice on how to increase the consumption of dietary iron and will be invited to participate in the study. Enrolled children will be randomized to either \>Your\< Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores (ferritin) and in hematological indices as well as occurence of any adverse events will be monitored after 4 and 12 weeks of once-daily supplementation with either \>Your\< Iron Syrup or placebo.
Interventions
DIETARY_SUPPLEMENT>Your< Iron Syrup
Once daily dose of \>Your\< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
OTHERPlacebo
Once daily dose of placebo syrup for 12 weeks
Sponsors
Clinres Farmacija d.o.o.
PharmaLinea Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age 9 months to 6 years (inclusive). * Signed informed consent for screening and for enrollment (parent or legal guardian). * Iron deficiency with or without mild microcytic anemia not requiring treatment (ferritin ≤20 µg/l and Hb ≥ 100 g/l in a capillary blood sample).
Exclusion criteria
* Hb \<100 g/l. * Anemia due to a cause other than iron deficiency. * Vegan diet. * Any known concomitant chronic disease (e. g., chronic inflammation, chronic inflammatory bowel disease, malignancy, kidney and/or liver malfunction, lead poisoning). * Any known allergies to the components of the investigational product. * Any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study. * Participation in another clinical study less than 1 month before enrollment or current participation in another clinical study. * Current consumption of iron-containing medicines or dietary supplements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of children having ferritin >20 µg/l | 12 weeks | Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average change in hemoglobin (Hb) | 4 weeks | Measurements in a capillary blood sample |
| Average change in Hb | 12 weeks | Measurement in a capillary blood sample |
| Average change in hematocrit (HCT) | 4 weeks | Measurement in a capillary blood sample |
| Average change in HCT | 12 weeks | Measurement in a capillary blood sample |
| Average change in mean corpuscular volume (MCV) | 4 weeks | Measurement in a capillary blood sample |
| The proportion of children having ferritin >20 µg/l | 4 weeks | Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP) |
| Average change in mean corpuscular hemoglobin (MCH) | 4 weeks | Measurement in a capillary blood sample |
| Average change in MCH | 12 weeks | Measurement in a capillary blood sample |
| Average change in mean corpuscular hemoglobin concentration (MCHC) | 4 weeks | Measurement in a capillary blood sample |
| Average change in MCHC | 12 weeks | Measurement in a capillary blood sample |
| Assessment of safety | 4 weeks | Collection and assessment of adverse events |
| Average change in MCV | 12 weeks | Measurement in a capillary blood sample |
Countries
Slovenia
Outcome results
None listed