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OpenTrials
Completed

NCT Number: NCT04130828

Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia

Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. Oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients. However, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. The current proposed study attempts to address this gap in the literature.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Patients with iron deficiency anemia defined as hemoglobin less than 12 g/dL in women or 13 g/dL in men; AND ferritin less than 30 ng/mL

Exclusion criteria

  • Allergy to iron
  • Currently pregnancy
  • Currently breastfeeding
  • Known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia
  • Renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2
  • Hepatic impairment or Child Pugh score more than 7
  • Active bleeding define hemoglobin decrease more than 2 g/dL
  • Multivitamin and mineral supplement (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
  • Non-literate

Subject withdrawal criteria:

  • Intolerance to drugs
  • Active bleeding define hemoglobin decrease more than 2 g/dL
  • Major surgery
  • Blood transfusion
  • Loss follow-up more than 2 weeks

Treatment and study plan

Ferrous fumarate

Drug

Ferrous fumarate 200 mg PO PC

Primary outcomes

  1. Proportion of patient who achieved hemoglobin target

    Time frame: 12 weeks

    Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks

Secondary outcomes

  1. Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events

    Time frame: 12 weeks

    Incidence of Treatment-Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Collaborators

  • The Thai Society of Hematology

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2019
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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