Ignite Creation Date:
2025-12-18 @ 8:38 AM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT00662285
Status:
None
Last Update Posted:
2008-04-21 00:00:00
First Post:
2008-04-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Description of Iron Status in Blood Donors
Sponsor:
None
Organization:
Study Overview
Official Title:
Description of Iron Status in Blood Donors
Status:
None
Status Verified Date:
2008-04
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: