The effect of long-term iron treatment on plasma isoprostanes in anaemic women
| ISRCTN | ISRCTN57167465 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57167465 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/08/2006
- Registration date
- 06/10/2006
- Last edited
- 04/02/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Catherine Geissler
Scientific
Scientific
Department of Nutrition and Dietetics
Kings College London
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
| Phone | +44 (0) 20 7848 4351 |
|---|---|
| catherine.geissler@kcl.ac.uk |
Study information
| Study design | Intervention study with only one subject group. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ISOPFe |
| Study objectives | 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. |
| Ethics approval(s) | Kings College London Research Ethics Committee will be looking at protocol on the 30th September 2006. |
| Health condition(s) or problem(s) studied | Iron deficiency anaemia |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Iron sulphate |
| Primary outcome measure | 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. |
| Overall study start date | 15/11/2006 |
| Completion date | 15/07/2007 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 16 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/11/2006 |
| Date of final enrolment | 15/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Nutrition and Dietetics
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
Kings College London (UK)
University/education
University/education
Hodgkin Building
Guys Campus
London
SE1 1UL
England
United Kingdom
| Phone | +44 (0) 20 7848 6981 |
|---|---|
| robert.lechler@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
Existing funds: C Geissler, School of Biomedical and Health Sciences, Kings College London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
