NCT04713943: IRON-SI

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

Completed NA Last updated 20 January 2021

What this trial tests

NA trial testing >Your< Iron Syrup in Iron-deficiency in 94 participants. Completed in 22 June 2020.

Timeline

22 December 2017

Primary endpoint
22 June 2020

22 June 2020

Quick facts

Lead sponsor	PharmaLinea Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	94
Start date	22 December 2017
Primary completion	22 June 2020
Estimated completion	22 June 2020
Sites	15 locations across Slovenia

Drugs / interventions tested

• >Your< Iron Syrup
• Placebo

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

PharmaLinea Ltd. — full company profile →

Who can join

Adults 9 Months to 6, any sex, with Iron-deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety.
   Zečkanović A, Kavčič M, Prelog T, Šmid A, et al · · 2021 · cited 5× · PMID 33810451 · DOI 10.3390/nu13041087