Description of Iron Status in Blood Donors

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00662285
First received: April 16, 2008
Last updated: April 18, 2008
Last verified: April 2008
  Purpose

Description of the effect of standard iron supplement on iron status in blood donors

Hypothesis:

For each person in each group (group a "without iron supplement" or group b "with iron supplement") individual biological variation in reticulocytes, tested day 1 and day 8 will be described. Groups a and b will be compared on iron status from day 1 and day 8.

  • H1 null: There is no significant intraindividual difference in reticstatus at day 1 and at day 8, in group a.
  • H2 null: There is no significant intraindividual difference in reticstatus at day 1 and at day 8, in group b
  • H3 null: There is no significant difference in iron status for the two groups, a and b, at day 1 and at day 8.

Condition Intervention
Iron Deficiency
Dietary Supplement: Iron supplement: Niferex 100 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Description of Iron Status in Blood Donors

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Iron status [ Time Frame: april 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin and serum ferritin [ Time Frame: april 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Niferex
100 mg Fe++
Dietary Supplement: Iron supplement: Niferex 100 mg
A: 100 mg pr day in 8 days

Detailed Description:

The purpose of the study:

The purpose of the study is to describe intra- individual biological variation in reticulocyte parameters in established blood donors. The aim is also to compare iron status and reticulocyte parameters in a group of established donors who are offered iron supplement, to a comparable group who are not offered iron supplement, at the time of donation and one week after donation.

Design:

The design is a prospective longitudinal intervention-study, with randomised subjects to iron supplement/ not iron supplement groups.

Materials and methods:

Each subject will be tested with an extended test repertoire at the time of donation, day one, and the same test repertoire will be repeated one week after donation, day eight. Iron supplement is defined as100 mg of iron-sulphate (Ferro retard), taken once a day. Subjects are randomised into two groups; group a: "no iron supplement", n = 100, and group b: "iron supplement", n = 100. These groups will be stratified according to gender and age. Randomising will be done without knowledge of earlier blood tests. Subjects are asked to participate as they arrive for blood donation, by oral and written information. Questionnaire for established donors are used at day one. Day eight, follow-up of iron supplements will be controlled.

Dropouts and withdrawal:

Subjects who do not receive iron supplement are at risk of developing iron deficiency. Criteria for transfer to treatment group will be:

  • Females: Hb < 12.5 g/dL
  • Males: Hb < 13.5 g/dL These subjects may continue as participants in the study, but with a description of transfer to treatment group including date and treatment type (iron supplement type and dose, dose interval, treatment time, termination of treatment).

Ethics:

The study is approved by the regional ethics committee. All subjects must sign informed consent.

Data analysis:

Univariate and multivariate analysis are use for iron status variables, with separate analysis for each gender. Baseline data are taken at day one, at donation, and follow up testing at day eight. Dependent variables are haemoglobin, S-ferritin, total reticulocytes count, haemoglobin content in reticulocytes and percent hypochromated red cells. Independent variables are gender, age, ironsupplement/ no iron supplement.

Biochemical tests:

Test methods are specified, and instruments described. Biochemical test are performed at lab for clinical biochemistry, Haukeland University Hospital, Bergen.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be accepted as blood donor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662285

Locations
Norway
Blood bank, Haukeland University Hospital,
Bergen, Norway, 5021
Blood bank
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Chair: Anne S Røsvik Aalesund University College
  More Information

No publications provided

Responsible Party: Haukeland University Hospital and University of Bergen, Blood bank and Institute of medicine
ClinicalTrials.gov Identifier: NCT00662285     History of Changes
Other Study ID Numbers: 16225
Study First Received: April 16, 2008
Last Updated: April 18, 2008
Health Authority: Norway: Haukeland University Hospital, Bergen

Keywords provided by Haukeland University Hospital:
iron status
blood donors

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014