Ferrous sulfate for Iron deficiency

Inclusion criteria

• {"criterion_text":"- Student at Polhemskolan, Lund\n- Age ≥15 years\n- Post-menarcheal\n- Written informed consent from the participant\n- Written informed consent from legal guardian(s) if <18 years\n- Serum ferritin <30 µg/L"}

Exclusion criteria

• {"criterion_text":"- Pregnancy\n- Chronic inflammatory disease (e.g. rheumatoid arthritis, Crohn’s disease)\n- Ongoing acute infection (e.g. tonsillitis, urinary tract infection)\n- CRP >10 mg/L\n- Current iron supplementation (except multivitamins)\n- Anaemia (Hb <110 g/L if <18 years; <117 g/L if ≥18 years, according to regional reference limits)\n- Iron overload (serum ferritin >150 µg/L; WHO definition)\n- Clinically significant vitamin B12 deficiency requiring immediate medical evaluation or treatment (e.g. serum vitamin B12 <150 pmol/L).\n- 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)."}

Primary endpoints

• {"endpoint_text":"- 1. Feasibility, including recruitment, retention, adherence and tolerability.\n- 2. Diagnostic performance of IRON-5 (sensitivity, specificity, positive and negative predictive values, and ROC-AUC).","definition_or_measurement_approach":"Feasibility measured by recruitment, retention, adherence and tolerability metrics. Diagnostic performance of IRON-5 measured by sensitivity, specificity, positive and negative predictive values and ROC-AUC versus ferritin-defined iron deficiency (ferritin <15 µg/L)."}

Secondary endpoints

• {"endpoint_text":"- Change in ferritin concentration.\n- Change in haemoglobin, TSAT, vitamin B12 and 25-hydroxyvitamin D from screening to follow-up.\n- 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).\n- 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).","definition_or_measurement_approach":"Change endpoints assessed from screening to follow-up for laboratory measures (ferritin, haemoglobin, TSAT, vitamin B12, 25-hydroxyvitamin D). Association endpoints explored using collected questionnaire and clinical data (dietary patterns, BMI, menstrual characteristics, physical activity, socioeconomic status, country of birth, fatigue and QoL measures)."}

Methods

• School-based recruitment: inclusion criterion specifies 'Student at Polhemskolan, Lund' indicating recruitment at Polhemskolan, Lund (Sweden).
• Recruitment materials: recruitment poster and other recruitment materials (document titles include 'K2_Recruitment poster_DRAFT_IRONGIRLS-PILOT' and 'K2_Beskrivning av rekryteringsmaterial_IRONGIRLS-PILOT').
• Digital/app-related: use of the Iron Smart app (document 'L2_Beskrivning av Iron Smart-appen') as part of the study/intervention and recruitment information.

Sweden

Earliest CTIS Part Ii Submission Date

01-04-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

13

Number Of Sites

1

Number Of Participants

279

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden