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Anemia in Inflammatory Bowel Disease (IBD)

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ClinicalTrials.gov Identifier: NCT02760940
Recruitment Status : Unknown
Verified May 2016 by Federal University of Juiz de Fora.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Federal University of Juiz de Fora

Brief Summary:
Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.

Condition or disease Intervention/treatment Phase
Anemia Bowel Diseases, Inflammatory Drug: oral liposomal iron Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anemia Treatment in Inflammatory Bowel Disease: Predictive Factors of Response to Oral Iron Treatment
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Oral liposomal iron treatment
Oral liposomal iron - 28 mg per day over 8 weeks
Drug: oral liposomal iron
After screening, anemic patients will be treated during 8 weeks with 28mg of oral liposomal iron per day and then the investigators will report data assessing the tolerability and efficacy of oral liposomal iron treatment in these patients.
Other Name: ferric pyrophosphate




Primary Outcome Measures :
  1. Hemoglobin level improvement [ Time Frame: 8 weeks ]
    The supplementation will be performed in patients with mild to moderate anemia, since patients with severe anemia usually require more aggressive treatments. The replenishment will be provided at no cost to the patients at the dose of 2 (two) iron liposomal iron tablet per day (equivalent to 28 mg of iron). The patients will be instructed to take one tablet of 14 mg twice a day. They will be monitored by telephone in weekly interval periods throughout the intervention phase in order to optimize their adhesion to the treatment and verify the occurrence of possible side effects and the improvement in hemoglobin level.


Secondary Outcome Measures :
  1. Improvement of quality of life [ Time Frame: 8 weeks ]
    The IBDQ questionnaire data will be applied before and after treatment. Our study will use the following quality of life classification: Equal to or higher than 200 = Excellent; Between 151 and 199 = Good; Between 101 and 150 = Regular; Lower than or equal to 100 = Poor.

  2. Improvement of fatigue [ Time Frame: 8 weeks ]

    The participants will be instructed to answer the questionnaire on fatigue (Chalder Fatigue Scale - attached) before and 8 weeks after the oral iron treatment.

    The questionnaire comprises 12 items related to the intensity of fatigue symptoms. It is a Likert-type scale with scores ranging from one to four in each item. The items are calculated in bimodal scores. Considering the Likert scale, the values ranging from one to four in bimodal calculations will be considered zero. Values such as three and four will be considered one. The sum in which the value is greater than or equal to four will feature fatigue


  3. Activation of inflammation [ Time Frame: 8 weeks ]
    The inflammatory activity will be assessed according to the Harvey-Bradshaw Index for CD patients and UC patients will be assessed according to the Truelove and Witts criteria.

  4. Improvement of anxiety and depression [ Time Frame: 8 weeks ]

    The participants will be instructed to answer the questionnaire on anxiety and depression (HAD scale) before and 8 weeks after the oral iron treatment.

    The questionnaire comprises 14 items related to anxiety and depression symptoms. It is considered anxiety if obtained 9 or more points, in items of anxiety and no-anxiety if below 8 points. The same criteria is used for depression.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis ) in remission
  • Anemia

Exclusion criteria:

  • Pre-existing liver disease
  • Kidney failure
  • Clinically significant pulmonary disease
  • Systemic infection
  • Pregnancy
  • Current history of any type of malignancy (except skin)
  • Gastrectomy
  • Total colectomy or extensive intestinal resection (> 100 cm )
  • Inflammatory bowel disease activity
  • Severe anemia.

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): NCT02760940


Contacts
Contact: Carla VA Antunes, Master +55(32)99123-1200 carlavaleria.aantunes@gmail.com
Contact: Julio MF Chebli, Doctor +5(32)991210949 chebli@globo.com

Sponsors and Collaborators
Federal University of Juiz de Fora
Investigators
Principal Investigator: Carla VA Antunes, MSc. MD Federal University of Juiz de Fora

Publications of Results:
Other Publications:

Responsible Party: Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT02760940     History of Changes
Other Study ID Numbers: CAAE:0200.0.200.000-10
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data will be published every 6 months until the end of the study

Keywords provided by Federal University of Juiz de Fora:
Inflammatory bowel diseases
Anemia
Crohn's disease
Ulcerative colitis
Oral iron
Quality of life

Additional relevant MeSH terms:
Anemia
Intestinal Diseases
Inflammatory Bowel Diseases
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs