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
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