Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
400 participants
INTERVENTIONAL
2008-04-30
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Niferex
100 mg Fe++
Iron supplement: Niferex 100 mg
A: 100 mg pr day in 8 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iron supplement: Niferex 100 mg
A: 100 mg pr day in 8 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
68 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Blood bank and Institute of medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne S Røsvik
Role: STUDY_CHAIR
Aalesund University College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Blood bank, Haukeland University Hospital,
Bergen, , Norway
Blood bank
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16225
Identifier Type: -
Identifier Source: org_study_id