Iron-deficiencyIRON-SINCT04713943
Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency
A study testing >Your< Iron Syrup in people with Iron-deficiency, run by PharmaLinea Ltd. at 15 sites in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 months to 6 years
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- >Your< Iron Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 15 sitesSlovenia
- Study dates
- 22 Dec 2017to 22 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Slovenia15 sites
Community Health Center Dr. Julija Polca Kamnik
Kamnik, 1241
Community Health Center Koper
Koper, 6000
Private Pediatric Practice Domagoj Puževski
Krško, 8270
Community Health Center Laško
Laško, 3270
Community Health Center Ljubljana - Moste-Polje, PE Polje
Ljubljana, 1000
Community Health Center Ljubljana - Moste-Polje
Ljubljana, 1000
Community Health Center Ljubljana - PE Rudnik
Ljubljana, 1000
Community Health Center Ljubljana - Šiška
Ljubljana, 1000
Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana
Ljubljana, 1000
Private Pediatric Practice Ajda Cimperman
Ljubljana, 1000
Community Health Center dr. Adolf Drolc Maribor
Maribor, 2000
Community Health Center Medvode
Medvode, 1215
Private Pediatric Practice Andreja Borinc Beden
Menges, 1234
General Hospital Dr. Franc Derganc Nova Gorica
Sempeter pri Gorici, 5290
Private Pediatric Practice Pediatrija Šentilj
Šentilj v Slovenskih goricah, 2212
About this study
Official 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
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
- Being tested
- >Your< Iron Syrup, Placebo
- Keywords
- Iron Supplement, Iron Deficiency, >Your< Iron Syrup
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
>Your< Iron SyrupDietary supplement
Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
PlaceboOther
Once daily dose of placebo syrup for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| >Your< Iron Syrup | Experimental | Not described Receives: Dietary Supplement: >Your< Iron Syrup |
| Placebo | Other | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of children having ferritin >20 µg/l
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Measured: 12 weeks
Secondary outcomes (13)
The proportion of children having ferritin >20 µg/l
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
Measured: 4 weeks
Average change in hemoglobin (Hb)
Measurements in a capillary blood sample
Measured: 4 weeks
Average change in Hb
Measurement in a capillary blood sample
Measured: 12 weeks
Average change in hematocrit (HCT)
Measurement in a capillary blood sample
Measured: 4 weeks
Average change in HCT
Measurement in a capillary blood sample
Measured: 12 weeks
Average change in mean corpuscular volume (MCV)
Measurement in a capillary blood sample
Measured: 4 weeks
Average change in MCV
Measurement in a capillary blood sample
Measured: 12 weeks
Average change in mean corpuscular hemoglobin (MCH)
Measurement in a capillary blood sample
Measured: 4 weeks
Average change in MCH
Measurement in a capillary blood sample
Measured: 12 weeks
Average change in mean corpuscular hemoglobin concentration (MCHC)
Measurement in a capillary blood sample
Measured: 4 weeks
Average change in MCHC
Measurement in a capillary blood sample
Measured: 12 weeks
Assessment of safety
Collection and assessment of adverse events
Measured: 4 weeks
Assessment of safety
Collection and assessment of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start22 Dec 2017
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaLinea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinres Farmacija d.o.o.
- Responsible party
- Sponsor
- Investigators
- Janez Jazbec, MD, PhD, Principal investigator, Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713943
- Sponsor's protocol ID
- PhL-2017-IRON-SI
- Acronym
- IRON-SI
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04713943
- Acronym / sponsor ID
- IRON-SI / PhL-2017-IRON-SI
- Conditions
- Iron-deficiency
- Keywords
- Iron Supplement, Iron Deficiency, >Your< Iron Syrup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- PharmaLinea Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clinres Farmacija d.o.o.
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| >Your< Iron Syrup | Experimental | Dietary Supplement: >Your< Iron Syrup |
| Placebo | Other | Other: Placebo |
Who may qualify
- Ages
- 9 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| >Your< Iron SyrupOnce daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks | Dietary supplement | >Your< Iron Syrup |
| PlaceboOnce daily dose of placebo syrup for 12 weeks | Other | Placebo |
Primary outcome
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)
13 secondary outcomes
The proportion of children having ferritin >20 µg/l
Time frame: 4 weeks
Average change in hemoglobin (Hb)
Time frame: 4 weeks
Average change in Hb
Time frame: 12 weeks
Average change in hematocrit (HCT)
Time frame: 4 weeks
Average change in HCT
Time frame: 12 weeks
Average change in mean corpuscular volume (MCV)
Time frame: 4 weeks
Average change in MCV
Time frame: 12 weeks
Average change in mean corpuscular hemoglobin (MCH)
Time frame: 4 weeks
Average change in MCH
Time frame: 12 weeks
Average change in mean corpuscular hemoglobin concentration (MCHC)
Time frame: 4 weeks
Average change in MCHC
Time frame: 12 weeks
Assessment of safety
Time frame: 4 weeks
Assessment of safety
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janez Jazbec, MD, PhD principal investigator
Department of Pediatric Hematology and Oncology, University Medical Centre Ljubljana
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing >Your< Iron Syrup in people with Iron-deficiency, run by PharmaLinea Ltd. at 15 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children having ferritin >20 µg/l (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.