Effect of intravenous iron in alleviating symptoms of exhaustion in non-anaemic pre-menopausal women

Effect of intravenous iron versus placebo on exhaustion symptoms in non-anaemic premenopausal women with low ferritin levels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78430425

Enrollment

100

Registered

2010-03-17

Start date

2006-09-21

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Reduced physical and mental performance in pre-menopausal women Nutritional, Metabolic, Endocrine

Interventions

Venofer®, (iron sucrose injection) is an aqueous complex of polynuclear iron (III)- hydroxide in sucrose for intravenous use. Patients received either 2 infusions each containing 200 mg iron [III]-hyd

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Premenopausal, regularly menstruating women 2. Age = 18 years 3. S-ferretin < 50ng/mL 4. Signed informed consent 5. Reduced physical and mental performance (fatigue, depressive mood, dizziness, sleep disturbance, concentration, neck pain, headache) as determined by investigator 6. Adequate contraception

Exclusion criteria

Exclusion criteria: 1. Haemoglobin (Hb) level 120 g/L 2. Known mental and physical disorder (cancer, depression) 3. Use of concomitant medication to cause symptoms of fatigue and depression (antidepressive & chemotherapeutic agents, sedatives) 4. Use of iron preparations within previous 4-weeks 5. Active sever infection, inflammation, malignancy 6. C-Reactive Protein (CRP) > 20 mg/mL 7. Thyroid-Stimulating Hormone (TSH) > 4 micro U/mL 8. Use of menstruation depressing gestagens 9. History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) 10. Significant cardiovascular disease e.g. unstable angina, New York Heart Association (NYHA) class IV 11. Hypersensitivity to iron sucrose or iron sulphate 12. Pregnancy or lactation 13. Participation in any other therapeutic study in the previous month

Design outcomes

Primary

Measure	Time frame
1. Brief Fatigue Inventory (total score = tBFI) assessed at baseline, day 42 and 90 2. Serum ferretin, assessed at baseline, 3rd treatment visit, day 42 and 90	—

Secondary

Measure	Time frame
1. BFI intensity mean score and impairment score, assessed at baseline, day 42 and 90 2. Haematological parameters, assessed at baseline, day 42 and 90 2.1. Hb 2.2. Mean corpuscular volume (MCV) 2.3. Mean corpuscular haemoglobin concentration (MCHC) 2.4. Haematocrit (HCT) 3. Iron status, assessed at baseline, 3rd treatment visit, day 42 and 90 3.1. Serum iron 3.2. Transferrin Saturation (Tsat) 3.3. Transferrin 4. Safety 4.1. Adverse effects 4.2. Physical exam, assessed at day 90 4.3. Body weight and height, assessed at day 90 4.4. Vital signs, assessed at baseline, day 42 and 90 4.5. Creatinine, assessed at baseline 4.6. Alanine Aminotransferase (ALT), assessed at baseline 4.7. Aspartate Aminotransferase (AST), assessed at baseline 4.8. C-Reactive protein (CRP), assessed at baseline, day 42 and 90 5. Concomitant medications	—

Measure

Time frame

1. BFI intensity mean score and impairment score, assessed at baseline, day 42 and 90 2. Haematological parameters, assessed at baseline, day 42 and 90 2.1. Hb 2.2. Mean corpuscular volume (MCV) 2.3. Mean corpuscular haemoglobin concentration (MCHC) 2.4. Haematocrit (HCT) 3. Iron status, assessed at baseline, 3rd treatment visit, day 42 and 90 3.1. Serum iron 3.2. Transferrin Saturation (Tsat) 3.3. Transferrin 4. Safety 4.1. Adverse effects 4.2. Physical exam, assessed at day 90 4.3. Body weight and height, assessed at day 90 4.4. Vital signs, assessed at baseline, day 42 and 90 4.5. Creatinine, assessed at baseline 4.6. Alanine Aminotransferase (ALT), assessed at baseline 4.7. Aspartate Aminotransferase (AST), assessed at baseline 4.8. C-Reactive protein (CRP), assessed at baseline, day 42 and 90 5. Concomitant medications

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026