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The effect of long-term iron treatment on serum NTBI and plasma isoprostanes in anaemic women versus an anaemic control group - NTBI and isoprostanes after long-term iron treatment

Phase 1
Conditions
Iron deficiency anaemia, defined as haemoglobin level <12 g/dl, mean cell volume <90 fl, serum ferritin <20 ug/l.
MedDRA version: 8.1Level: LLTClassification code 10022972Term: Iron deficiency anaemia
Registration Number
EUCTR2006-005407-33-GB
Lead Sponsor
King's College London
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
30
Inclusion Criteria

For the purposes of this study, we intend to recruit women of child-bearing age (18-50 years) only, as this sector of the population is the primary target group for supplemental iron. Only women age 18 - 50 with iron deficiency anaemia (haemoglobin < 12g/dl, mean cell volume < 90fl and serum ferritin < 20ug/l) will be included in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals will be excluded from partaking in this study if they:
- suffer from serious chronic illness - have a body mass index above 30 - are a smoker - are taking prescription drugs including contraceptive medicines - regularly take medicines containing aspirin or ibuprofen - are pregnant or breastfeeding - are planning to become pregnant in the next 2 months
- or have moderately/severely elevated cholesterol (>6.0 mmol/l), as these factors affect either iron absorption or plasma isoprostane concentration.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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