Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
279
Countries
1
Sites
1
iron deficiency in adolescent girls
1. To evaluate the feasibility of Duroferon 100 mg administered on alternate days in combination with Iron Smart, compared with placebo plus Iron Smart, in adolescent girls with iron deficiency. 2. To evaluate the diagnostic performance of IRON-5 in identifying iron deficiency (ferritin <15 µg/L).
Key facts
- Sponsor
- Region Skane
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Female
- Therapeutic area
- Not possible to specify, Health Care [N] - Environment and Public Health [N06]
- Decision date (initial)
- 2026-04-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Others
1. To evaluate the feasibility of Duroferon 100 mg administered on alternate days in combination with Iron Smart, compared with placebo plus Iron Smart, in adolescent girls with iron deficiency.
2. To evaluate the diagnostic performance of IRON-5 in identifying iron deficiency (ferritin <15 µg/L).
Secondary objectives 4
- To assess change in ferritin concentration from screening to follow-up.
- To assess change in haemoglobin, transferrin saturation (TSAT), vitamin B12 and 25-hydroxyvitamin D from screening to follow-up.
- To explore factors associated with iron deficiency (e.g. dietary patterns, BMI, menstrual characteristics, physical activity, socioeconomic status and country of birth).
- To explore factors other than iron deficiency associated with fatigue and self-rated QoL (e.g. vitamin B12/25-hydroxyvitamin D status, anxiety/depression and lifestyle factors).
Conditions and MedDRA coding
iron deficiency in adolescent girls
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Student at Polhemskolan, Lund
- Age ≥15 years
- Post-menarcheal
- Written informed consent from the participant
- Written informed consent from legal guardian(s) if <18 years
- Serum ferritin <30 µg/L
Exclusion criteria 9
- Pregnancy
- Chronic inflammatory disease (e.g. rheumatoid arthritis, Crohn’s disease)
- Ongoing acute infection (e.g. tonsillitis, urinary tract infection)
- CRP >10 mg/L
- Current iron supplementation (except multivitamins)
- Anaemia (Hb <110 g/L if <18 years; <117 g/L if ≥18 years, according to regional reference limits)
- Iron overload (serum ferritin >150 µg/L; WHO definition)
- Clinically significant vitamin B12 deficiency requiring immediate medical evaluation or treatment (e.g. serum vitamin B12 <150 pmol/L).
- Use of medication known to interfere with iron absorption or cause clinically significant interaction with oral iron (e.g. fluoroquinolones, tetracyclines, bisphosphonates, levodopa, methyldopa, aluminium- or magnesium-containing antacids), defined as regular or daily use (≥3 times per week).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Feasibility, including recruitment, retention, adherence and tolerability. 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).
Secondary endpoints 4
- Change in ferritin concentration.
- Change in haemoglobin, TSAT, vitamin B12 and 25-hydroxyvitamin D from screening to follow-up.
- Associations between iron deficiency and selected factors (dietary patterns, BMI, menstrual characteristics including bleeding volume, menstrual pain and analgesic use, hormonal contraceptive use, physical activity, socioeconomic status and country of birth).
- Associations between fatigue and self-rated QoL and factors other than iron deficiency (e.g. vitamin B12 and vitamin D deficiency, anxiety/depression and lifestyle factors).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2132930 · Product
- Active substance
- Ferrous Sulfate
- Substance synonyms
- IRON SULFATE, FERROUS SULPHATE, IRON (II)-SULFATE
- Pharmaceutical form
- MODIFIED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 4500 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- B03AA07 — FERROUS SULFATE
- Marketing authorisation
- 5680
- MA holder
- ACO HUD NORDIC AB
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane
- Contact name
- Clinical trial team
Public contact point
- Organisation
- Region Skane
- Contact name
- Clinical trial team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 279 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Trial_protocol_IRONGIRLS_2025-522498-12-00 | 1.1 |
| Protocol (for publication) | D4_Questionnaire_baseline | 1 |
| Protocol (for publication) | D4_Questionnaire_follow-up | 1 |
| Protocol (for publication) | D4_Symptom diary | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ 2025-522498-12-00 | 1 |
| Recruitment arrangements (for publication) | K2_Beskrivning av rekryteringsmaterial_IRONGIRLS-PILOT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment poster_DRAFT_IRONGIRLS-PILOT | 1 |
| Subject information and informed consent form (for publication) | L1_Re-consent_18 years | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_trial participant | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_Legal_guardian | 1.1 |
| Subject information and informed consent form (for publication) | L2_Beskrivning av Iron Smart-appen | 1 |
| Subject information and informed consent form (for publication) | L2_Draft examples of participant laboratory result notifications | 1 |
| Subject information and informed consent form (for publication) | L2_Information for participants in the treatment phase | 1 |
| Subject information and informed consent form (for publication) | L2_Participant contact card_IRONGIRLS-PILOT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duroferon | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-522498-12-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-13 | Sweden | Acceptable 2026-04-14
|
2026-04-14 |