NCT00662285

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

Same day

First QC Date

April 16, 2008

Last Update Submit

April 18, 2008

Conditions

Iron Deficiency

Keywords

iron statusblood donors

Outcome Measures

Primary Outcomes (1)

  • Iron status

    april 2008

Secondary Outcomes (1)

  • Hemoglobin and serum ferritin

    april 2008

Study Arms (1)

A: Niferex

OTHER

100 mg Fe++

Dietary Supplement: Iron supplement: Niferex 100 mg

Interventions

Iron supplement: Niferex 100 mgDIETARY_SUPPLEMENT

A: 100 mg pr day in 8 days

A: Niferex

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be accepted as blood donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blood bank, Haukeland University Hospital,

Bergen, 5021, Norway

Location

Blood bank

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anne S Røsvik

    Aalesund University College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

NO(2)