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临床试验/NCT03873584
NCT03873584撤回不适用

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

Elpen Pharmaceutical Co. Inc.0 个研究点开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Fatigue Symptoms in Iron Deficiency Anaemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Fatigue Symptoms in Iron Deficiency Anaemia

时间窗: 3 months

Fatigue Assessment Scale (FAS) rating

次要结局

  • Hemoglobin levels(3 months)

研究者

申办方类型
Industry
责任方
Sponsor

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