A low-intervention randomised, double-blind, placebo-controlled pilot trial evaluating the feasibility, tolerability and adherence of alternate-day oral Duroferon (ferrous sulphate) in adolescent girls with iron deficiency, and the diagnostic performance of the IRON-5 screening tool (IRONGIRLS-PILOT).

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522498-12-00

Enrollment

279

Registered

2026-04-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

iron deficiency in adolescent girls

Brief summary

1. Feasibility, including recruitment, retention, adherence and tolerability. 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).

Detailed description

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).

Interventions

DRUGDuroferon depottabletter

DRUGDuroferon placebo

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 15, 2026