Phase 4 N=154 Randomized Quadruple-blind Treatment

Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors

Fatigue · Iron Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00689793 ↗

Enrolled (actual)

154

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcome: Primary: Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. — 3.4; 3.5 centimeter — p=0.69

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ferrous sulphate (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Lausanne
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.	3.4; 3.5	0.69
SECONDARY Hemoglobin Variation Before and After Treatment vs Placebo	135; 130	<0.05 sig
SECONDARY Ferritin Change Before and After 4 Weeks of Treatment/Placebo	28.0; 12.9	<0.05 sig
SECONDARY Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test	40.5; 40.1	0.05
SECONDARY Response of Iron Supplementation on Mental Disorder	3; 4	—
SECONDARY Adherence to Treatment.	96; 96	—

Summary

The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.

Eligibility Criteria

Inclusion Criteria

women
aged 18 - 50
eligible for a blood donation

Exclusion Criteria

men
age below 18 or above 50
not eligible for a blood donation (according to the blood donation eligibility guidelines of the Swiss Red Cross)
hemochromatosis, psychiatric / thyroid / hepatic / rheumatismal / kidney or cardiopulmonary diseases that can cause fatigue
intestinal disease or medical treatment that can perturb iron absorption and/or excretion
donors with mental disorder or psychiatric disease that are unable to give consent
acute or chronic inflammation
diabetes and pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00689793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.