Anemia in Inflammatory Bowel Disease (IBD)
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|ClinicalTrials.gov Identifier: NCT02760940|
Recruitment Status : Not yet recruiting
First Posted : May 4, 2016
Last Update Posted : August 9, 2016
|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)|
|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|
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
- 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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Carla VA Antunes, Master||+55(32)email@example.com|
|Contact: Julio MF Chebli, Doctor||+5(32)firstname.lastname@example.org|
|Principal Investigator:||Carla VA Antunes, MSc. MD||Federal University of Juiz de Fora|