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Completed

NCT Number: NCT00689793

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

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.

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Key information

Conditions

Fatigue Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne

Lausanne, Bugnon 44, 1011, Switzerland

About this study

  • Actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. Furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation.
  • 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.
  • We will measure blood count, ferritin level and C-reactive protein at the time of the blood donation and then after a week, a month and 3 months.

A week after the blood donation, donors with a ferritin level <30 ng/ml and hemoglobin > 120g/l (non anaemic) will be included in the study and randomised. A one-month iron treatment vs placebo will be introduced. To assess the subjective response on fatigue, the donors will fill in different questionnaires at the time of the blood donation and then after a week, a month and 3 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous sulphate

Drug

Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.

Other names: Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm, Fer, Sulphate de fer, Sulphate ferreux, Iron deficiency

Placebo

Drug

Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.

Other names: Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm, Fer, Sulphate de fer, Sulphate ferreux, Iron deficiency

Primary outcomes

  1. Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.

    Time frame: baseline and 4 weeks

    The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from "no fatigue=0" to "very severe fatigue=10".

Secondary outcomes

  1. Hemoglobin Variation Before and After Treatment vs Placebo

    Time frame: baseline and 4 weeks

    The level of hemoglobin measured 4 weeks after randomization

  2. Ferritin Change Before and After 4 Weeks of Treatment/Placebo

    Time frame: baseline and 4 weeks

    Level of ferritin measured 4 weeks after randomization

  3. Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test

    Time frame: baseline and 4 weeks

    Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.

  4. Response of Iron Supplementation on Mental Disorder

    Time frame: baseline and 4 weeks

    Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment.

  5. Adherence to Treatment.

    Time frame: 4 weeks

    Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Pierre Fabre Laboratories

Registry information

Official study title

Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial

Acronym: ferdon

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 4, 2008
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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