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

NCT04713943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-01-20

No results posted yet for this study

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.

Conditions

  • Iron-deficiency

Interventions

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

Sponsors & Collaborators

  • Clinres Farmacija d.o.o.

    collaborator INDUSTRY

  • PharmaLinea Ltd.

    lead INDUSTRY

Principal Investigators

  • Janez Jazbec, MD, PhD · Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2020-06-22
Completion
2020-06-22

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713943 on ClinicalTrials.gov