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

Primary Purpose

Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
>Your< Iron Syrup
Placebo
Sponsored by
PharmaLinea Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Iron-deficiency focused on measuring Iron Supplement, Iron Deficiency, >Your< Iron Syrup

Eligibility Criteria

9 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Health Center Dr. Julija Polca Kamnik
  • Community Health Center Koper
  • Private Pediatric Practice Domagoj Puževski
  • Community Health Center Laško
  • Community Health Center Ljubljana - Moste-Polje, PE Polje
  • Community Health Center Ljubljana - Moste-Polje
  • Community Health Center Ljubljana - PE Rudnik
  • Community Health Center Ljubljana - Šiška
  • Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana
  • Private Pediatric Practice Ajda Cimperman
  • Community Health Center dr. Adolf Drolc Maribor
  • Community Health Center Medvode
  • Private Pediatric Practice Andreja Borinc Beden
  • General Hospital Dr. Franc Derganc Nova Gorica
  • Private Pediatric Practice Pediatrija Šentilj

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

>Your< Iron Syrup

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 14, 2021
Last Updated
January 15, 2021
Sponsor
PharmaLinea Ltd.
Collaborators
Clinres Farmacija d.o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT04713943
Brief Title
Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
Acronym
IRON-SI
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
June 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaLinea Ltd.
Collaborators
Clinres Farmacija d.o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
Iron Supplement, Iron Deficiency, >Your< Iron Syrup

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
>Your< Iron Syrup
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
>Your< Iron Syrup
Intervention Description
Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Once daily dose of placebo syrup for 12 weeks
Primary Outcome Measure Information:
Title
The proportion of children having ferritin >20 µg/l
Description
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The proportion of children having ferritin >20 µg/l
Description
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Time Frame
4 weeks
Title
Average change in hemoglobin (Hb)
Description
Measurements in a capillary blood sample
Time Frame
4 weeks
Title
Average change in Hb
Description
Measurement in a capillary blood sample
Time Frame
12 weeks
Title
Average change in hematocrit (HCT)
Description
Measurement in a capillary blood sample
Time Frame
4 weeks
Title
Average change in HCT
Description
Measurement in a capillary blood sample
Time Frame
12 weeks
Title
Average change in mean corpuscular volume (MCV)
Description
Measurement in a capillary blood sample
Time Frame
4 weeks
Title
Average change in MCV
Description
Measurement in a capillary blood sample
Time Frame
12 weeks
Title
Average change in mean corpuscular hemoglobin (MCH)
Description
Measurement in a capillary blood sample
Time Frame
4 weeks
Title
Average change in MCH
Description
Measurement in a capillary blood sample
Time Frame
12 weeks
Title
Average change in mean corpuscular hemoglobin concentration (MCHC)
Description
Measurement in a capillary blood sample
Time Frame
4 weeks
Title
Average change in MCHC
Description
Measurement in a capillary blood sample
Time Frame
12 weeks
Title
Assessment of safety
Description
Collection and assessment of adverse events
Time Frame
4 weeks
Title
Assessment of safety
Description
Collection and assessment of adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janez Jazbec, MD, PhD
Organizational Affiliation
Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Center Dr. Julija Polca Kamnik
City
Kamnik
ZIP/Postal Code
1241
Country
Slovenia
Facility Name
Community Health Center Koper
City
Koper
ZIP/Postal Code
6000
Country
Slovenia
Facility Name
Private Pediatric Practice Domagoj Puževski
City
Krško
ZIP/Postal Code
8270
Country
Slovenia
Facility Name
Community Health Center Laško
City
Laško
ZIP/Postal Code
3270
Country
Slovenia
Facility Name
Community Health Center Ljubljana - Moste-Polje, PE Polje
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Community Health Center Ljubljana - Moste-Polje
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Community Health Center Ljubljana - PE Rudnik
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Community Health Center Ljubljana - Šiška
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Private Pediatric Practice Ajda Cimperman
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Community Health Center dr. Adolf Drolc Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Community Health Center Medvode
City
Medvode
ZIP/Postal Code
1215
Country
Slovenia
Facility Name
Private Pediatric Practice Andreja Borinc Beden
City
Mengeš
ZIP/Postal Code
1234
Country
Slovenia
Facility Name
General Hospital Dr. Franc Derganc Nova Gorica
City
Šempeter Pri Gorici
ZIP/Postal Code
5290
Country
Slovenia
Facility Name
Private Pediatric Practice Pediatrija Šentilj
City
Šentilj v Slovenskih goricah
ZIP/Postal Code
2212
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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