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

Sponsor
Elpen Pharmaceutical Co. Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03873584
Collaborator
(none)
2,400
12.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Fatigue Symptoms in Iron Deficiency Anaemia [3 months]

    Fatigue Assessment Scale (FAS) rating

Secondary Outcome Measures

  1. Hemoglobin levels [3 months]

    Evaluation of iron succinylate treatment in improving hematological parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Elpen Pharmaceutical Co. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT03873584
Other Study ID Numbers:
  • 2019-IRPS-EL-99
First Posted:
Mar 13, 2019
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022