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Trial record 1 of 1 for:    20081092 [PUBMED-IDS]
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The Correlation Between Anemia of Chronic Diseases, Hepcidin and Vitamin D in IBD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03145896
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
Crohn's disease (CD) and ulcerative colitis (UC) are chronic gastrointestinal diseases characterized by relapsing and remitting inflammation of the intestines Anemia may often complicate the course of inflammatory bowel disease (IBD). The cause of anemia in IBD is multifactorial In the chronically ill patients, it has been described that the mechanism underlying anemia involves hepcidin.A potential mechanism underlying anemia during an chronic disease is suggested by recent data demonstrating a hepcidin lowering effect of vitamin D

Condition or disease Intervention/treatment Phase
IBD Dietary Supplement: vitamin D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Correlation Between Anemia of Chronic Diseases, Hepcidin and Vitamin D in IBD Patients
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: IBD patients with Vitamin D treatment Dietary Supplement: vitamin D
After the gastroscopy all patients will be taught to take 4000 unit of vitamin D (25(OH)D) daily (not a specific brand) , for the next 2 week. All patients will be invited for follow-up in 2 weeks to get the histopathology result. In this encounter we will take again blood sample for 25(OH)D, calcium, phosphate, CRP and complete blood count including hemoglobin. a control group will not take the Vitamin D supplements.

No Intervention: IBD patients with no Vitamin D treatment

Primary Outcome Measures :
  1. influence of vitamin D on anemia of inflammation [ Time Frame: 2 weeks ]
    levels of hepcidin, IL6, vitamin D and anemia in children and adolescence with newly diagnosed IBD before and after vitamin D supplemntation.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with newly diagnosed IBD based on histopathology.

Exclusion Criteria:

  • Patients that their histopathology will confirm eventually different diagnosis.
  • Participants that are receiving medications known to alter vitamin D metabolism or have hepatic or renal disease
  • Participants that suffer from hemoglobinopaties, bone marrow failure, or receive bone marrow suppressing agents
  • Participants that went through a recent surgical procedure, or needed blood transfusion for any reason


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Responsible Party: michal roll, Phd, Tel-Aviv Sourasky Medical Center Identifier: NCT03145896     History of Changes
Other Study ID Numbers: TASMC-15-SC-0778-CTIL
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
vitamin D

Additional relevant MeSH terms:
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Chronic Disease
Hematologic Diseases
Disease Attributes
Pathologic Processes
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Infective Agents