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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Dietary supplement: >Your< Iron Syrup; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Kamnik, Slovenia, 1241
    • Community Health Center Dr. Julija Polca Kamnik
  • Koper, Slovenia, 6000
    • Community Health Center Koper
  • Krško, Slovenia, 8270
    • Private Pediatric Practice Domagoj Puževski
  • Laško, Slovenia, 3270
    • Community Health Center Laško
  • Ljubljana, Slovenia, 1000
    • 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
  • Maribor, Slovenia, 2000
    • Community Health Center dr. Adolf Drolc Maribor
  • Medvode, Slovenia, 1215
    • Community Health Center Medvode
  • Mengeš, Slovenia, 1234
    • Private Pediatric Practice Andreja Borinc Beden
  • Šempeter Pri Gorici, Slovenia, 5290
    • General Hospital Dr. Franc Derganc Nova Gorica
  • Šentilj v Slovenskih goricah, Slovenia, 2212
    • Private Pediatric Practice Pediatrija Šentilj

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Placebo	Other: Placebo; Once daily dose of placebo syrup for 12 weeks
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PharmaLinea Ltd.
• Collaborators: Clinres Farmacija d.o.o.
• Investigators: Principal Investigator: Janez Jazbec, MD, PhD, Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): June 22, 2020
• Study Completion (Actual): June 22, 2020

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Iron Deficiency; Iron Supplement; >Your< Iron Syrup
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: PhL-2017-IRON-SI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No