Iron DeficiencyNCT00662285
Description of Iron Status in Blood Donors
A study testing Iron supplement: Niferex 100 mg in people with Iron Deficiency, run by Haukeland University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Iron supplement: Niferex 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be accepted as blood donor
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Blood bank, Haukeland University Hospital,
Bergen, 5021
Blood bank
Bergen, 5021
About this study
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.
Read the 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.
- Conditions
- Iron Deficiency
- Being tested
- Iron supplement: Niferex 100 mg
- Keywords
- iron status, blood donors
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplement: Niferex 100 mgDietary supplement
A: 100 mg pr day in 8 days
| Study group | Role | What they receive |
|---|---|---|
| A: Niferex | Other | 100 mg Fe++ Receives: Dietary Supplement: Iron supplement: Niferex 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
Measured: april 2008
Secondary outcomes (1)
Hemoglobin and serum ferritin
Measured: april 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2008 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anne S Røsvik, Study chair, Aalesund University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662285
- Sponsor's protocol ID
- 16225
- Status last verified
- Apr 2008
- First submitted
- 16 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Iron Status in Blood Donors
- ClinicalTrials.gov ID
- NCT00662285
- Acronym / sponsor ID
- 16225
- Conditions
- Iron Deficiency
- Keywords
- iron status, blood donors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: Niferex | Other | Dietary Supplement: Iron supplement: Niferex 100 mg100 mg Fe++ |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be accepted as blood donor
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron supplement: Niferex 100 mgA: 100 mg pr day in 8 days | Dietary supplement | A: Niferex |
Primary outcome
Iron status
Time frame: april 2008
1 secondary outcome
Hemoglobin and serum ferritin
Time frame: april 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne S Røsvik study chair
Aalesund University College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron supplement: Niferex 100 mg in people with Iron Deficiency, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status (time frame: april 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2008.