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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03873584
Acronym
IFAISTOS
Enrollment
0
Registered
2019-03-13
Start date
2022-09-01
Completion date
2023-09-30
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Fatigue, Iron-deficiency, Iron Deficiency Anemia

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.

Interventions

OTHERFatigue

Iron deficiency anemia with fatigue symptoms

Sponsors

Elpen Pharmaceutical Co. Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Symptoms in Iron Deficiency Anaemia3 monthsFatigue Assessment Scale (FAS) rating

Secondary

MeasureTime frameDescription
Hemoglobin levels3 monthsEvaluation of iron succinylate treatment in improving hematological parameters

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026