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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005407-33-GB

Enrollment

Registered

2006-10-16

Start date

2006-11-08

Completion date

Unknown

Last updated

2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia, defined as haemoglobin level <12 g/dl, mean cell volume <90 fl, serum ferritin <20 ug/l. MedDRA version: 8.1 Level: LLT Classification code 10022972 Term: Iron deficiency anaemia

Interventions

Trade Name: Ferrous Sulphate Product Name: Ferrous Sulphate 200 mg tablets Pharmaceutical Form: Tablet Current Sponsor code: KCL/CG02/2006 Other descriptive name: IRON (Fe2+) Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Plasma F2 isoprostanes and serum non-transferrin bound iron (NTBI).	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Plasma F2 isoprostanes and serum non-transferrin bound iron (NTBI).

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026