NCT04713943

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: PharmaLinea Ltd. · Industry
• Sex: All
• Age: 9 Months – 6 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-06-22
• Completion: 2020-06-22
• First posted: 2021-01-19
• Last updated: 2021-01-20

Locations

15 sites across 1 country: Slovenia