Description of Iron Status in Blood Donors

Iron Deficiency Clinical Trial

Official title:

Description of Iron Status in Blood Donors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00662285
• Other study ID #: 16225
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 16, 2008
• Last updated: April 18, 2008
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2008
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Haukeland University Hospital, Bergen
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• Must be accepted as blood donor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• Iron supplement: Niferex 100 mg
A: 100 mg pr day in 8 days

Locations

Country	Name	City	State
Norway	Blood bank	Bergen
Norway	Blood bank, Haukeland University Hospital,	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron status		april 2008	No
Secondary	Hemoglobin and serum ferritin		april 2008	No