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

NCT04713943 | Completed

• 1 other identifier: PhL-2017-IRON-SI
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 15

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, 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

Keywords

Iron Supplement; Iron Deficiency; >Your< Iron Syrup

Outcome Measures

Primary Outcomes (1)

• The proportion of children having ferritin >20 µg/l

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

  12 weeks

Secondary Outcomes (13)

• The proportion of children having ferritin >20 µg/l

  4 weeks

• Average change in hemoglobin (Hb)

  4 weeks

• Average change in Hb

  12 weeks

• Average change in hematocrit (HCT)

  4 weeks

• Average change in HCT

  12 weeks

Study Arms (2)

>Your< Iron Syrup

EXPERIMENTAL

Dietary Supplement: >Your< Iron Syrup

Placebo

OTHER

Other: Placebo

Interventions

>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

>Your< Iron Syrup

Placebo OTHER

Once daily dose of placebo syrup for 12 weeks

Placebo

Eligibility Criteria

• Age: 9 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaLinea Ltd.: lead
• Clinres Farmacija d.o.o.: collaborator

Study Sites (15)

Community Health Center Dr. Julija Polca Kamnik

Kamnik, 1241, Slovenia

Location

Community Health Center Koper

Koper, 6000, Slovenia

Location

Private Pediatric Practice Domagoj Puževski

Krško, 8270, Slovenia

Location

Community Health Center Laško

Laško, 3270, Slovenia

Location

Community Health Center Ljubljana - Moste-Polje, PE Polje

Ljubljana, 1000, Slovenia

Location

Community Health Center Ljubljana - Moste-Polje

Ljubljana, 1000, Slovenia

Location

Community Health Center Ljubljana - PE Rudnik

Ljubljana, 1000, Slovenia

Location

Community Health Center Ljubljana - Šiška

Ljubljana, 1000, Slovenia

Location

Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Private Pediatric Practice Ajda Cimperman

Ljubljana, 1000, Slovenia

Location

Community Health Center dr. Adolf Drolc Maribor

Maribor, 2000, Slovenia

Location

Community Health Center Medvode

Medvode, 1215, Slovenia

Location

Private Pediatric Practice Andreja Borinc Beden

Mengeš, 1234, Slovenia

Location

General Hospital Dr. Franc Derganc Nova Gorica

Šempeter pri Gorici, 5290, Slovenia

Location

Private Pediatric Practice Pediatrija Šentilj

Šentilj v Slovenskih goricah, 2212, Slovenia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Janez Jazbec, MD, PhD

  Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: December 22, 2017
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (15)