Status:
COMPLETED
Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
Lead Sponsor:
PharmaLinea Ltd.
Collaborating Sponsors:
Clinres Farmacija d.o.o.
Conditions:
Iron-deficiency
Eligibility:
All Genders
9-6 years
Phase:
NA
Brief 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, dou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04713943
Start Date
December 22 2017
End Date
June 22 2020
Last Update
January 20 2021
Active Locations (15)
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1
Community Health Center Dr. Julija Polca Kamnik
Kamnik, Slovenia, 1241
2
Community Health Center Koper
Koper, Slovenia, 6000
3
Private Pediatric Practice Domagoj Puževski
Krško, Slovenia, 8270
4
Community Health Center Laško
Laško, Slovenia, 3270