Clinical trial NCT03873584: Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anemia
Iron-deficiency
Iron Deficiency Anemia
Fatigue
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2400 iron deficient patients with fatigue symptoms who are treated with iron succinylate.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fatigue Symptoms in Iron Deficiency Anaemia
timeFrame: 3 months
Secondary outcomes:
measure: Hemoglobin levels
timeFrame: 3 months
Other outcomes:
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Study officials:
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