The effect of long-term iron treatment on plasma isoprostanes in anaemic women | Stopped
The effect of long-term iron treatment on plasma isoprostanes in anaemic women
ISOPFe
Trial Source

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Health Conditions
  • Iron deficiency anaemia
Prof Catherine Geissler
+44 (0) 20 7848 4351
See all trial contact details
Primary Contact Details
Stopped
Recruitment Status
ISRCTN57167465
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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.
Phase
Not Specified
Study Design
Intervention study with only one subject group.
Study Type
Interventional
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
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.
Publication(s)
Sorry, this information is not available
Result Reports
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Gender
Female
Age Range
Adult
Who Can Participate
Patient
Number of Participants
16
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 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
Trial Location(s)
Diabetes & Nutritional Sciences Division, King's College London
London
SE1 9NH
Trial Contact(s)
Primary Trial Contact
Prof Catherine Geissler
catherine.geissler@kcl.ac.uk
+44 (0) 20 7848 4351
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Sorry, this information is not available
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Existing funds: C Geissler, School of Biomedical and Health Sciences, Kings College London (UK)
Other Study ID Numbers
N/A
Sponsor(s)
Kings College London (UK)
Key Dates

Recruitment Start Date

15 Nov 2006

Recruitment End Date

15 Jul 2007

Trial Start Date

15 Nov 2006

Trial End Date

15 Jul 2007

Date Assigned

06 Oct 2006

Last Updated

04 Feb 2011