Clinical trial NCT04713943: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Keywords: Iron Supplement
Iron Deficiency
>Your< Iron Syrup
Lead sponsor: PharmaLinea Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clinres Farmacija d.o.o.
First posted: 2021-01-19
Enrollment: 94
Sex: ALL
Minimum age (years): 9
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The proportion of children having ferritin >20 µg/l
timeFrame: 12 weeks
Secondary outcomes:
measure: The proportion of children having ferritin >20 µg/l
timeFrame: 4 weeks
measure: Average change in hemoglobin (Hb)
timeFrame: 4 weeks
measure: Average change in Hb
timeFrame: 12 weeks
measure: Average change in hematocrit (HCT)
timeFrame: 4 weeks
measure: Average change in HCT
timeFrame: 12 weeks
measure: Average change in mean corpuscular volume (MCV)
timeFrame: 4 weeks
measure: Average change in MCV
timeFrame: 12 weeks
measure: Average change in mean corpuscular hemoglobin (MCH)
timeFrame: 4 weeks
measure: Average change in MCH
timeFrame: 12 weeks
measure: Average change in mean corpuscular hemoglobin concentration (MCHC)
timeFrame: 4 weeks
measure: Average change in MCHC
timeFrame: 12 weeks
measure: Assessment of safety
timeFrame: 4 weeks
measure: Assessment of safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kamnik
country: Slovenia
facility: Community Health Center Dr. Julija Polca Kamnik
city: Koper
country: Slovenia
facility: Community Health Center Koper
city: Krško
country: Slovenia
facility: Private Pediatric Practice Domagoj Puževski
city: Laško
country: Slovenia
facility: Community Health Center Laško
city: Ljubljana
country: Slovenia
facility: Community Health Center Ljubljana - Moste-Polje, PE Polje
city: Ljubljana
country: Slovenia
facility: Community Health Center Ljubljana - Moste-Polje
city: Ljubljana
country: Slovenia
facility: Community Health Center Ljubljana - PE Rudnik
city: Ljubljana
country: Slovenia
facility: Community Health Center Ljubljana - Šiška
city: Ljubljana
country: Slovenia
facility: Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana
city: Ljubljana
country: Slovenia
facility: Private Pediatric Practice Ajda Cimperman
city: Maribor
country: Slovenia
facility: Community Health Center dr. Adolf Drolc Maribor
city: Medvode
country: Slovenia
facility: Community Health Center Medvode
city: Mengeš
country: Slovenia
facility: Private Pediatric Practice Andreja Borinc Beden
city: Šempeter Pri Gorici
country: Slovenia
facility: General Hospital Dr. Franc Derganc Nova Gorica
city: Šentilj v Slovenskih goricah
country: Slovenia
facility: Private Pediatric Practice Pediatrija Šentilj
Study officials:
affiliation: Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
name: Janez Jazbec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: