Phase 4
N=88
Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate
Ulcerative Colitis · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01991314 ↗Enrolled (actual)
88
Serious AEs
3.4%
Results posted
Mar 2017
Primary outcome: Primary: Mean Change in Haemoglobin Concentration. — 1.22; 1.30 g/dl — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ferrous sulphate (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Queen Mary University of London
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Haemoglobin Concentration. |
1.22; 1.30 | 0.23 |
| SECONDARY Intolerance of Oral Iron |
10; 8 | <0.05 sig |
| SECONDARY Change in Disease Activity (Stool Calprotectin) |
-35; -40 | 0.96 |
| SECONDARY Change in Quality of Life Score |
3.2; 5.7 | 0.49 |
| SECONDARY Changes in Anxiety |
-0.7; -1.1 | 0.85 |
| SECONDARY Changes in Fatigue |
0.9; 1.9 | 0.69 |
| SECONDARY Changes in Stress Levels |
4.1; -11.8 | <0.0001 sig |
Summary
Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy.
IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity.
To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.
Eligibility Criteria
Inclusion Criteria
Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 - 18 will be considered adolescents, and aged >18 as adults.
Exclusion Criteria
Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females.
Data sourced from ClinicalTrials.gov (NCT01991314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.