Condition category
Haematological Disorders
Date applied
30/08/2006
Date assigned
06/10/2006
Last edited
04/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Catherine Geissler

ORCID ID

Contact details

Department of Nutrition and Dietetics
Kings College London
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 (0) 20 7848 4351
catherine.geissler@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ISOPFe

Study hypothesis

Serum non-transferrin-bound iron (NTBI) and plasma isoprostanes will be significantly increased in samples collected immediately following 200 mg FeSO4 (65 mg iron) daily for 28 days, compared with before treatment, and compared with a control group who will not receive iron treatment.

Parametric tests (paired Student's t-test and one-way Analysis Of Variance [ANOVA]) will be used to determine the change in serum NTBI, plasma F2-isoprostanes and haemoglobin from visit one (baseline) to visit two within the treatment group, and the difference in the change in variables between the treatment group and control group, from visit one to visit two.

Ethics approval

Kings College London Research Ethics Committee will be looking at protocol on the 30th September 2006.

Study design

Intervention study with only one subject group.

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Iron deficiency anaemia

Intervention

Subjects with iron deficiency anaemia will be recruited and will be randomly assigned to either a treatment (n = 15) or control group (n = 15). Subjects in the treatment group will receive 200 mg FeSO4 (65 mg iron) once daily for 28 days. Controls will NOT receive a placebo, but will be instructed not to change their diet/lifestyle habits over a period of 28 days. In these subjects, plasma isoprostanes and serum NTBI will be measured at the start of the start of the study, and 28 days after their allocation to the control group.

All subjects will be asked to complete a seven day estimated diet diary, starting on the day after their allocation to either the treatment or control group, in order to examine the relationship between dietary antioxidant intakes and isoprostane levels in all subjects.

Intervention type

Drug

Phase

Not Specified

Drug names

Iron sulphate

Primary outcome measures

Plasma isoprostane concentration after daily iron treatment for 28 days.

Secondary outcome measures

The secondary outcome is serum NTBI. In addition to measuring the primary outcome (plasma isoprostanes) before and once after once daily ferrous sulphate treatment for 28 days, we will also measure serum NTBI before and once after daily ferrous sulphate treatment for 28 days in all subjects.

Overall trial start date

15/11/2006

Overall trial end date

15/07/2007

Reason abandoned

Lack of funding

Eligibility

Participant inclusion criteria

1. Females aged 18 to 50 years
2. Iron deficiency anaemia, defined as haemoglobin less than 12 g/dl, and mean corpuscular volume (MCV) less than 90 fl and serum ferritin less than 20 ug/l

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

16

Participant exclusion criteria

1. Suffer from serious chronic illness
2. Body mass index above 30
3. Smoker
4. Taking prescription drugs including contraceptive medicines
5. Regularly take medicines containing aspirin or ibuprofen
6. Pregnant or breastfeeding or are planning to become pregnant in the next two months
7. Moderately/severely elevated cholesterol (more than 6.0 mmol/l), as these factors affect either iron absorption or plasma isoprostane concentration

Recruitment start date

15/11/2006

Recruitment end date

15/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Nutrition and Dietetics
London
SE1 9NH
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

Hodgkin Building
Guys Campus
London
SE1 1UL
United Kingdom
+44 (0) 20 7848 6981
robert.lechler@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

University/education

Funder name

Existing funds: C Geissler, School of Biomedical and Health Sciences, Kings College London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes