>Your< Iron Syrup
Dietary SupplementOnce daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
NCT Number: NCT04713943
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.
Looking for future studies?
Notify Me9 month–6 year
All sexes
Interventional
Not applicable
Community Health Center Dr. Julija Polca Kamnik, Kamnik, Slovenia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
Once daily dose of placebo syrup for 12 weeks
Time frame: 12 weeks
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Time frame: 4 weeks
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Time frame: 4 weeks
Measurements in a capillary blood sample
Time frame: 12 weeks
Measurement in a capillary blood sample
Time frame: 4 weeks
Measurement in a capillary blood sample
Time frame: 12 weeks
Measurement in a capillary blood sample
Time frame: 4 weeks
Measurement in a capillary blood sample
Time frame: 12 weeks
Measurement in a capillary blood sample
Time frame: 4 weeks
Measurement in a capillary blood sample
Time frame: 12 weeks
Measurement in a capillary blood sample
Time frame: 4 weeks
Measurement in a capillary blood sample
Time frame: 12 weeks
Measurement in a capillary blood sample
Time frame: 4 weeks
Collection and assessment of adverse events
Time frame: 12 weeks
Collection and assessment of adverse events
PharmaLinea Ltd.
Industry
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
Acronym: IRON-SI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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