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Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency (IRON-SI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713943
Recruitment Status : Completed
First Posted : January 19, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Clinres Farmacija d.o.o.
Information provided by (Responsible Party):
PharmaLinea Ltd.

Study Description
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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
Iron-deficiency Dietary Supplement: >Your< Iron Syrup Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 22, 2017
Actual Primary Completion Date : June 22, 2020
Actual Study Completion Date : June 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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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
Placebo Other: Placebo
Once daily dose of placebo syrup for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of children having ferritin >20 µg/l [ Time Frame: 12 weeks ]
    Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)


Secondary Outcome Measures :
  1. The proportion of children having ferritin >20 µg/l [ Time Frame: 4 weeks ]
    Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

  2. Average change in hemoglobin (Hb) [ Time Frame: 4 weeks ]
    Measurements in a capillary blood sample

  3. Average change in Hb [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample

  4. Average change in hematocrit (HCT) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample

  5. Average change in HCT [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample

  6. Average change in mean corpuscular volume (MCV) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample

  7. Average change in MCV [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample

  8. Average change in mean corpuscular hemoglobin (MCH) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample

  9. Average change in MCH [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample

  10. Average change in mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample

  11. Average change in MCHC [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample

  12. Assessment of safety [ Time Frame: 4 weeks ]
    Collection and assessment of adverse events

  13. Assessment of safety [ Time Frame: 12 weeks ]
    Collection and assessment of adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713943


Locations
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Slovenia
Community Health Center Dr. Julija Polca Kamnik
Kamnik, Slovenia, 1241
Community Health Center Koper
Koper, Slovenia, 6000
Private Pediatric Practice Domagoj Puževski
Krško, Slovenia, 8270
Community Health Center Laško
Laško, Slovenia, 3270
Community Health Center Ljubljana - Moste-Polje, PE Polje
Ljubljana, Slovenia, 1000
Community Health Center Ljubljana - Moste-Polje
Ljubljana, Slovenia, 1000
Community Health Center Ljubljana - PE Rudnik
Ljubljana, Slovenia, 1000
Community Health Center Ljubljana - Šiška
Ljubljana, Slovenia, 1000
Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Private Pediatric Practice Ajda Cimperman
Ljubljana, Slovenia, 1000
Community Health Center dr. Adolf Drolc Maribor
Maribor, Slovenia, 2000
Community Health Center Medvode
Medvode, Slovenia, 1215
Private Pediatric Practice Andreja Borinc Beden
Mengeš, Slovenia, 1234
General Hospital Dr. Franc Derganc Nova Gorica
Šempeter Pri Gorici, Slovenia, 5290
Private Pediatric Practice Pediatrija Šentilj
Šentilj v Slovenskih goricah, Slovenia, 2212
Sponsors and Collaborators
PharmaLinea Ltd.
Clinres Farmacija d.o.o.
Investigators
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Principal Investigator: Janez Jazbec, MD, PhD Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
More Information
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Responsible Party: PharmaLinea Ltd.
ClinicalTrials.gov Identifier: NCT04713943    
Other Study ID Numbers: PhL-2017-IRON-SI
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PharmaLinea Ltd.:
Iron Supplement
Iron Deficiency
>Your< Iron Syrup
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
 Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases