Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of >Your< Iron Syrup Supplementation in Children With Iron Deficiency With or Without Mild Microcytic Anemia - a Double-Blind, Placebo-Controlled Multicentric Clinical Study

Conditions
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Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: >Your< Iron Syrup
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: >Your< Iron Syrup<br> | Dietary Supplement: >Your< Iron Syrup<br>* Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks<br>|
| Other: Placebo<br> | Other: Placebo<br>* Once daily dose of placebo syrup for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of children having ferritin >20 µg/l | Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of children having ferritin >20 µg/l | Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP) | 4 weeks | 
| Average change in hemoglobin (Hb) | Measurements in a capillary blood sample | 4 weeks | 
| Average change in Hb | Measurement in a capillary blood sample | 12 weeks | 
| Average change in hematocrit (HCT) | Measurement in a capillary blood sample | 4 weeks | 
| Average change in HCT | Measurement in a capillary blood sample | 12 weeks | 
| Average change in mean corpuscular volume (MCV) | Measurement in a capillary blood sample | 4 weeks | 
| Average change in MCV | Measurement in a capillary blood sample | 12 weeks | 
| Average change in mean corpuscular hemoglobin (MCH) | Measurement in a capillary blood sample | 4 weeks | 
| Average change in MCH | Measurement in a capillary blood sample | 12 weeks | 
| Average change in mean corpuscular hemoglobin concentration (MCHC) | Measurement in a capillary blood sample | 4 weeks | 
| Average change in MCHC | Measurement in a capillary blood sample | 12 weeks | 
| Assessment of safety | Collection and assessment of adverse events | 4 weeks | 
| Assessment of safety | Collection and assessment of adverse events | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron Supplement, Iron Deficiency, >Your< Iron Syrup