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Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

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ClinicalTrials.gov Identifier: NCT01991314
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 7, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Brief 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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Drug: Ferrous sulphate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This was an open label trial
Primary Purpose: Treatment
Official Title: Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue
Study Start Date : December 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Ferrous sulphate
Ferrous sulphate 200mg twice daily for 6 weeks
Drug: Ferrous sulphate
200mg tablets.




Primary Outcome Measures :
  1. Mean Change in Haemoglobin Concentration. [ Time Frame: Baseline (0 weeks) and end of trial (6 weeks) ]
    Change in serum Hb concentration in g/dl after 6 weeks of oral iron


Secondary Outcome Measures :
  1. Intolerance of Oral Iron [ Time Frame: Baseline (0 weeks) to end of trial (6 weeks) ]
    Numbers of patients who reported intolerance of oral iron (abdominal pain, nausea, vomiting, constipation, diarrhoea or headache)

  2. Change in Disease Activity (Stool Calprotectin) [ Time Frame: Baseline (0 weeks) and end of trial (6 weeks) ]
    Difference between faecal calprotectin measured at baseline and at end of study

  3. Change in Quality of Life Score [ Time Frame: Baseline (0 weeks) to end (6 weeks) ]
    Short Inflammatory Bowel Disease Questionnaire (SIBDQ score), a health-related quality of life tool measuring physical, social, and emotional status (summated to produce a score of minimum 10 to maximum 70, representing poor to good quality of life, respectively). (Reporting of individual domain subscores is not valid).

  4. Changes in Anxiety [ Time Frame: Baseline (0 weeks) and end of trial (6 weeks) ]
    Hospital Anxiety and Depression Score (HADS)-A, a scale of 7 questions score 0-3 each, so that total score 0 is good and 21 very severe anxiety.

  5. Changes in Fatigue [ Time Frame: Baseline (0 weeks) and end of trial (6 weeks) ]
    Multidimensional Fatigue Inventory (MFI) is a 20 question-based scale with total scores ranging between 20 (very good) and 100 (very severe fatigue).

  6. Changes in Stress Levels [ Time Frame: Baseline (0 weeks) and end of trial (6 weeks) ]
    Perceived Stress Questionnaire (PSQ)-G is a 30-question measure of perceived stress giving total scores ranging between 30 (very unstressed) to 120 (very stressed).



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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991314


Locations
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United Kingdom
Barts Health NHS Trust
London, United Kingdom, E11 BB
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: David S Rampton, DPhil, FRCP Queen Mary London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01991314     History of Changes
Other Study ID Numbers: 2010-023797-39
First Posted: November 25, 2013    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: May 9, 2017
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases