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

Anemia Clinical Trial

— IFAISTOS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03873584
• Other study ID #: 2019-IRPS-EL-99
• Status: Withdrawn
• Start date: September 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Fatigue
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

Other:
• Fatigue
Iron deficiency anemia with fatigue symptoms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Symptoms in Iron Deficiency Anaemia	Fatigue Assessment Scale (FAS) rating	3 months
Secondary	Hemoglobin levels	Evaluation of iron succinylate treatment in improving hematological parameters	3 months