IRON-SI: Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: >Your< Iron Syrup
|
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
|
| Other: Placebo
|
Other: Placebo
Once daily dose of placebo syrup for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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
- Average change in MCV [12 weeks]
Measurement in a capillary blood sample
- 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
- Assessment of safety [12 weeks]
Collection and assessment of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 9 months to 6 years (inclusive).
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Signed informed consent for screening and for enrollment (parent or legal guardian).
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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.
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Anemia due to a cause other than iron deficiency.
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Vegan diet.
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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.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Community Health Center Dr. Julija Polca Kamnik | Kamnik | Slovenia | 1241 | |
| 2 | Community Health Center Koper | Koper | Slovenia | 6000 | |
| 3 | Private Pediatric Practice Domagoj Puževski | Krško | Slovenia | 8270 | |
| 4 | Community Health Center Laško | Laško | Slovenia | 3270 | |
| 5 | Community Health Center Ljubljana - Moste-Polje, PE Polje | Ljubljana | Slovenia | 1000 | |
| 6 | Community Health Center Ljubljana - Moste-Polje | Ljubljana | Slovenia | 1000 | |
| 7 | Community Health Center Ljubljana - PE Rudnik | Ljubljana | Slovenia | 1000 | |
| 8 | Community Health Center Ljubljana - Šiška | Ljubljana | Slovenia | 1000 | |
| 9 | Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana | Ljubljana | Slovenia | 1000 | |
| 10 | Private Pediatric Practice Ajda Cimperman | Ljubljana | Slovenia | 1000 | |
| 11 | Community Health Center dr. Adolf Drolc Maribor | Maribor | Slovenia | 2000 | |
| 12 | Community Health Center Medvode | Medvode | Slovenia | 1215 | |
| 13 | Private Pediatric Practice Andreja Borinc Beden | Mengeš | Slovenia | 1234 | |
| 14 | General Hospital Dr. Franc Derganc Nova Gorica | Šempeter Pri Gorici | Slovenia | 5290 | |
| 15 | Private Pediatric Practice Pediatrija Šentilj | Šentilj v Slovenskih goricah | Slovenia | 2212 |
Sponsors and Collaborators
- PharmaLinea Ltd.
- Clinres Farmacija d.o.o.
Investigators
- Principal Investigator: Janez Jazbec, MD, PhD, Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PhL-2017-IRON-SI