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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.

Tracking Information
First Submitted Date  ICMJE January 14, 2021
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE December 22, 2017
Actual Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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)
  • Average change in hemoglobin (Hb) [ Time Frame: 4 weeks ]
    Measurements in a capillary blood sample
  • Average change in Hb [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample
  • Average change in hematocrit (HCT) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample
  • Average change in HCT [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample
  • Average change in mean corpuscular volume (MCV) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample
  • Average change in MCV [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample
  • Average change in mean corpuscular hemoglobin (MCH) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample
  • Average change in MCH [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample
  • Average change in mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: 4 weeks ]
    Measurement in a capillary blood sample
  • Average change in MCHC [ Time Frame: 12 weeks ]
    Measurement in a capillary blood sample
  • Assessment of safety [ Time Frame: 4 weeks ]
    Collection and assessment of adverse events
  • Assessment of safety [ Time Frame: 12 weeks ]
    Collection and assessment of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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)
  • Average change in hemoglobin, hematocrit, MCV, MCH and MCHC [ Time Frame: 4 weeks ]
    Measurements in a capillary blood sample
  • Average change in hemoglobin, hematocrit, MCV, MCH and MCHC [ Time Frame: 12 weeks ]
    Measurements in a capillary blood sample
  • Assessment of safety [ Time Frame: 12 weeks ]
    Collection and assessment of adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Iron-deficiency
Intervention  ICMJE
  • 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
    Once daily dose of placebo syrup for 12 weeks
Study Arms  ICMJE
  • Experimental: >Your< Iron Syrup
    Intervention: Dietary Supplement: >Your< Iron Syrup
  • Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2021)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 22, 2020
Actual Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04713943
Other Study ID Numbers  ICMJE PhL-2017-IRON-SI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party PharmaLinea Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PharmaLinea Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Clinres Farmacija d.o.o.
Investigators  ICMJE
Principal Investigator: Janez Jazbec, MD, PhD Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
PRS Account PharmaLinea Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP