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OpenTrials
Completed

NCT Number: NCT04713943

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

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.

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Key information

Age range

9 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Center Dr. Julija Polca Kamnik, Kamnik, Slovenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

>Your< Iron Syrup

Dietary Supplement

Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks

Placebo

Other

Once daily dose of placebo syrup for 12 weeks

Primary outcomes

  1. The proportion of children having ferritin >20 µg/l

    Time frame: 12 weeks

    Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

Secondary outcomes

  1. The proportion of children having ferritin >20 µg/l

    Time frame: 4 weeks

    Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)

  2. Average change in hemoglobin (Hb)

    Time frame: 4 weeks

    Measurements in a capillary blood sample

  3. Average change in Hb

    Time frame: 12 weeks

    Measurement in a capillary blood sample

  4. Average change in hematocrit (HCT)

    Time frame: 4 weeks

    Measurement in a capillary blood sample

  5. Average change in HCT

    Time frame: 12 weeks

    Measurement in a capillary blood sample

  6. Average change in mean corpuscular volume (MCV)

    Time frame: 4 weeks

    Measurement in a capillary blood sample

  7. Average change in MCV

    Time frame: 12 weeks

    Measurement in a capillary blood sample

  8. Average change in mean corpuscular hemoglobin (MCH)

    Time frame: 4 weeks

    Measurement in a capillary blood sample

  9. Average change in MCH

    Time frame: 12 weeks

    Measurement in a capillary blood sample

  10. Average change in mean corpuscular hemoglobin concentration (MCHC)

    Time frame: 4 weeks

    Measurement in a capillary blood sample

  11. Average change in MCHC

    Time frame: 12 weeks

    Measurement in a capillary blood sample

  12. Assessment of safety

    Time frame: 4 weeks

    Collection and assessment of adverse events

  13. Assessment of safety

    Time frame: 12 weeks

    Collection and assessment of adverse events

Sponsors and collaborators

Lead sponsor

PharmaLinea Ltd.

Industry

Collaborators

  • Clinres Farmacija d.o.o.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Jan 20, 2021

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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