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Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy (IFAISTOS)

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: NCT03873584
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:

The treatment of anemia depends on its cause. Patients with underlying iron-deficient anemia should be treated or referred to a specialist (eg gynecologist, gastroenterologist) for treatment.deficiency anemia are global health problems and common medical conditions seen in everyday clinical practice.

Iron is vital for biological functions, such as breathing, energy production, DNA synthesis, and cell proliferation.

Iron deficiency refers to the reduction of iron stores and precedes the occurrence of iron deficiency anemia.

Iron deficiency anemia is a more severe condition in which low levels of iron are associated with anemia and the presence of small cellular red blood cells.

Condition or disease Intervention/treatment
Anemia Iron-deficiency Iron Deficiency Anemia Fatigue Other: Fatigue

Detailed Description:

The diagnosis of anemia is based on the patient's symptoms and blood tests. Blood tests refer to hemoglobin, hematocrit, and the number of red blood cells (per cubic centimeter or millet of blood). Also, the status of iron stores in the body can be measured by measuring ferritin. With these blood tests it can be determined Per os treatment: The dosage of elemental iron required to treat anemia due to iron deficiency in adults is 120 mg per day for three months. An increase in hemoglobin by 1g / dl after one month of treatment shows an adequate response to treatment and confirms the diagnosis. In adults, treatment should be continued for three months after correction of anemia to allow replenishment of iron stores.

Patient noncompliance may be an obstacle to oral therapy due to the occurrence of gastrointestinal side effects such as epigastric discomfort, nausea, diarrhea and constipation. These effects can be reduced when iron is taken with meals but its absorption can be reduced by 40%.

In addition, taking medications such as proton pump inhibitors and agents that reduce gastric acid hypersecretion (eg chronic atrophic gastritis, recent gastrectomy or abdominal incision) reduce iron absorption.

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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Multi-center, Non-interventional, Prospective, Clinical Observational Study to Evaluate the Efficacy of Iron Protein Succinylate in Improving Fatigue Symptoms in Patients With Iron Deficiency Anemia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Fatigue Iron

Intervention Details:
  • Other: Fatigue
    Iron deficiency anemia with fatigue symptoms

Primary Outcome Measures :
  1. Fatigue Symptoms in Iron Deficiency Anaemia [ Time Frame: 3 months ]
    Fatigue Assessment Scale (FAS) rating

Secondary Outcome Measures :
  1. Hemoglobin levels [ Time Frame: 3 months ]
    Evaluation of iron succinylate treatment in improving hematological parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2400 iron deficient patients with fatigue symptoms who are treated with iron succinylate.

Inclusion Criteria:

  • 16-90 yers
  • Iron deficiency anemia
  • Treatment with iron succinylate
  • Fatigue symptoms
  • Informed Consent
  • Compliance with study procedures

Exclusion Criteria:

  • Anemia caused by other parameters (non-iron-deficiency)

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Responsible Party: Elpen Pharmaceutical Co. Inc. Identifier: NCT03873584     History of Changes
Other Study ID Numbers: 2019-IRPS-EL-99
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Signs and Symptoms
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs