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

NCT04130828 | Completed Phase 3 DMC

• 1 other identifier: REC.62-404-14-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia

Keywords

ferrous fumarate; oral iron treatment; thrice-weekly; thrice-daily; iron deficiency anemia

Outcome Measures

Primary Outcomes (1)

• Proportion of patient who achieved hemoglobin target

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

  12 weeks

Secondary Outcomes (1)

• Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events

  12 weeks

Study Arms (2)

Thrice-weekly group

EXPERIMENTAL

Ferrous fumarate 200 mg PO PC Thrice-weekly

Drug: Ferrous Fumarate

Thrice-daily group

ACTIVE COMPARATOR

Ferrous fumarate 200 mg PO PC Thrice-daily

Drug: Ferrous Fumarate

Interventions

Ferrous Fumarate DRUG

Ferrous fumarate 200 mg PO PC

Thrice-daily group; Thrice-weekly group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead
• The Thai Society of Hematology: collaborator

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Pharmaceutical scienes

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: January 21, 2020
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)