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

Health Conditions
  • Iron deficiency anaemia
Stopped
Recruitment Status
ISRCTN57167465
Primary Trial ID Number
Summary
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.
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.
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Kings College London Research Ethics Committee will be looking at protocol on the 30th September 2006.
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
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
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Intervention study with only one subject group.
Results Reporting
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Acronym
ISOPFe
Scientific Title
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Secondary Trial Identifying Number
N/A
Website
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Study Funded By
Existing funds: C Geissler, School of Biomedical and Health Sciences, Kings College London (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Kings College London (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

15 Nov 2006

Recruitment End Date

15 Jul 2007

Trial End Date

15 Jul 2007

Date added to Registry

06 Oct 2006

Last Updated

04 Feb 2011