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

PharmaLinea Ltd.94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Iron-deficiency

Interventions

Eligibility

Sex: ALLMin age: 9 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (15)

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 - Moste-Polje, PE Polje

Ljubljana, Slovenia

Community Health Center Ljubljana - Moste-Polje

Ljubljana, Slovenia

Community Health Center Ljubljana - PE Rudnik

Ljubljana, Slovenia

Community Health Center Ljubljana - Šiška

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

...and 5 more locations

Outcomes

Primary Outcomes

The proportion of children having ferritin >20 µg/l

Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

Time frame: 12 weeks

Secondary Outcomes

The proportion of children having ferritin >20 µg/l

Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

Time frame: 4 weeks

Average change in hemoglobin (Hb)

Measurements in a capillary blood sample

Time frame: 4 weeks

Average change in Hb