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

• ClinicalTrials.gov Identifier: NCT04713943
• Recruitment Status: Completed
• First Posted: January 19, 2021
• Last Update Posted: January 20, 2021
• Sponsor: PharmaLinea Ltd.
• Collaborator: Clinres Farmacija d.o.o.
• Information provided by (Responsible Party): PharmaLinea Ltd.

Tracking Information

• First Submitted Date: January 14, 2021
• First Posted Date: January 19, 2021
• Last Update Posted Date: January 20, 2021
• Actual Study Start Date: December 22, 2017
• Actual Primary Completion Date: June 22, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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 (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: Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Other
• Condition: Iron-deficiency

Intervention

• 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

• Experimental: >Your< Iron Syrup
  Intervention: Dietary Supplement: >Your< Iron Syrup
• Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2021): 94
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 22, 2020
• Actual Primary Completion Date: June 22, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Months to 6 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Slovenia

Administrative Information

• NCT Number: NCT04713943
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: PharmaLinea Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: PharmaLinea Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Clinres Farmacija d.o.o.

Investigators

• Principal Investigator: Janez Jazbec, MD, PhD; Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana

• PRS Account: PharmaLinea Ltd.
• Verification Date: January 2021