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

Iron-deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713943
• Other study ID #: PhL-2017-IRON-SI
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: June 22, 2020

Study information

• Verified date: January 2021
• Source: PharmaLinea Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• 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

Locations

Country	Name	City	State
Slovenia	General Hospital Dr. Franc Derganc Nova Gorica	Šempeter Pri Gorici
Slovenia	Private Pediatric Practice Pediatrija Šentilj	Šentilj v Slovenskih goricah
Slovenia	Community Health Center Dr. Julija Polca Kamnik	Kamnik
Slovenia	Community Health Center Koper	Koper
Slovenia	Private Pediatric Practice Domagoj Puževski	Krško
Slovenia	Community Health Center Laško	Laško
Slovenia	Community Health Center Ljubljana - Šiška	Ljubljana
Slovenia	Community Health Center Ljubljana - Moste-Polje	Ljubljana
Slovenia	Community Health Center Ljubljana - Moste-Polje, PE Polje	Ljubljana
Slovenia	Community Health Center Ljubljana - PE Rudnik	Ljubljana
Slovenia	Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana	Ljubljana
Slovenia	Private Pediatric Practice Ajda Cimperman	Ljubljana
Slovenia	Community Health Center dr. Adolf Drolc Maribor	Maribor
Slovenia	Community Health Center Medvode	Medvode
Slovenia	Private Pediatric Practice Andreja Borinc Beden	Mengeš

Sponsors (2)

Lead Sponsor	Collaborator
PharmaLinea Ltd.	Clinres Farmacija d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of children having ferritin >20 µg/l	Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)	4 weeks
Secondary	Average change in hemoglobin (Hb)	Measurements in a capillary blood sample	4 weeks
Secondary	Average change in Hb	Measurement in a capillary blood sample	12 weeks
Secondary	Average change in hematocrit (HCT)	Measurement in a capillary blood sample	4 weeks
Secondary	Average change in HCT	Measurement in a capillary blood sample	12 weeks
Secondary	Average change in mean corpuscular volume (MCV)	Measurement in a capillary blood sample	4 weeks
Secondary	Average change in MCV	Measurement in a capillary blood sample	12 weeks
Secondary	Average change in mean corpuscular hemoglobin (MCH)	Measurement in a capillary blood sample	4 weeks
Secondary	Average change in MCH	Measurement in a capillary blood sample	12 weeks
Secondary	Average change in mean corpuscular hemoglobin concentration (MCHC)	Measurement in a capillary blood sample	4 weeks
Secondary	Average change in MCHC	Measurement in a capillary blood sample	12 weeks
Secondary	Assessment of safety	Collection and assessment of adverse events	4 weeks
Secondary	Assessment of safety	Collection and assessment of adverse events	12 weeks