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

Completed

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

Registration Number: ISRCTN78430425

Lead Sponsor: Vifor Pharma, Vifor (International) Ltd (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 100

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Brief Fatigue Inventory (total score = tBFI) assessed at baseline, day 42 and 90<br>2. Serum ferretin, assessed at baseline, 3rd treatment visit, day 42 and 90

Secondary Outcome Measures

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