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

Not Applicable

Completed

• Conditions: Iron-deficiency
• Interventions: Dietary Supplement: >Your< Iron Syrup; Other: Placebo

• Registration Number: NCT04713943
• Lead Sponsor: PharmaLinea Ltd.

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 available

Study Timeline

• Study Start: 2017-12-22
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
>Your< Iron Syrup	>Your< Iron Syrup	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The proportion of children having ferritin >20 µg/l	12 weeks	Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Community Health Center Dr. Julija Polca Kamnik; 🇸🇮 Kamnik, 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 - PE Rudnik; 🇸🇮 Ljubljana, Slovenia

Private Pediatric Practice Ajda Cimperman; 🇸🇮 Ljubljana, Slovenia

Community Health Center Ljubljana - Moste-Polje; 🇸🇮 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

Community Health Center Koper; 🇸🇮 Koper, Slovenia

Private Pediatric Practice Andreja Borinc Beden; 🇸🇮 Mengeš, Slovenia

Community Health Center dr. Adolf Drolc Maribor; 🇸🇮 Maribor, Slovenia

General Hospital Dr. Franc Derganc Nova Gorica; 🇸🇮 Šempeter Pri Gorici, Slovenia

Community Health Center Medvode; 🇸🇮 Medvode, Slovenia

Private Pediatric Practice Pediatrija Šentilj; 🇸🇮 Šentilj v Slovenskih goricah, Slovenia