E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anaemia, defined as haemoglobin level <12 g/dl, mean cell volume <90 fl, serum ferritin <20 ug/l. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022972 |
E.1.2 | Term | Iron deficiency anaemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this trial is to determine whether long-term supplementation of therapuetic doses of oral iron in the form of ferrous sulphate is associated with raised plasma F2-isoprostanes (markers of oxidative damage) in women with iron deficiency anaemia. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this trial is to determine whether long-term supplementation of therapeutic doses of oral iron in the form of ferrous sulphate is associated with raised levels of potentially pro-oxidant serum NTBI in women with iron deficiency anaemia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma F2 isoprostanes and serum non-transferrin bound iron (NTBI). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
A control group without treatment or placebo |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the point when the last subject has attended their second and final day of blood sampling. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |