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| Name | Class |
|---|---|
| Clinres Farmacija d.o.o. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| >Your< Iron Syrup | Experimental |
| |
| Placebo | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| >Your< Iron Syrup | Dietary Supplement | Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janez Jazbec, MD, PhD | Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Center Dr. Julija Polca Kamnik | Kamnik | 1241 | Slovenia | |||
| Community Health Center Koper |
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| Placebo | Other | Once daily dose of placebo syrup for 12 weeks |
|
| 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 |
| Koper |
| 6000 |
| Slovenia |
| Private Pediatric Practice Domagoj Puževski | Krško | 8270 | Slovenia |
| Community Health Center Laško | Laško | 3270 | Slovenia |
| Community Health Center Ljubljana - Moste-Polje, PE Polje | Ljubljana | 1000 | Slovenia |
| Community Health Center Ljubljana - Moste-Polje | Ljubljana | 1000 | Slovenia |
| Community Health Center Ljubljana - PE Rudnik | Ljubljana | 1000 | Slovenia |
| Community Health Center Ljubljana - Šiška | Ljubljana | 1000 | Slovenia |
| Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| Private Pediatric Practice Ajda Cimperman | Ljubljana | 1000 | Slovenia |
| Community Health Center dr. Adolf Drolc Maribor | Maribor | 2000 | Slovenia |
| Community Health Center Medvode | Medvode | 1215 | Slovenia |
| Private Pediatric Practice Andreja Borinc Beden | Menges | 1234 | Slovenia |
| General Hospital Dr. Franc Derganc Nova Gorica | Sempeter pri Gorici | 5290 | Slovenia |
| Private Pediatric Practice Pediatrija Šentilj | Šentilj v Slovenskih goricah | 2212 | Slovenia |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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