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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Ferrous Fumarate

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring ferrous fumarate, oral iron treatment, thrice-weekly, thrice-daily, iron deficiency anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Songklanagarind Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thrice-weekly group

Thrice-daily group

Arm Description

Ferrous fumarate 200 mg PO PC Thrice-weekly

Ferrous fumarate 200 mg PO PC Thrice-daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events

Full Information

NCT ID

NCT04130828

First Posted

October 16, 2019

Last Updated

February 12, 2022

Sponsor

Prince of Songkla University

Collaborators

The Thai Society of Hematology

1. Study Identification

Unique Protocol Identification Number

NCT04130828

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

January 18, 2022 (Actual)

Study Completion Date

January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

Collaborators

The Thai Society of Hematology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thrice-weekly group

Arm Type

Experimental

Arm Description

Ferrous fumarate 200 mg PO PC Thrice-weekly

Arm Title

Thrice-daily group

Arm Type

Active Comparator

Arm Description

Ferrous fumarate 200 mg PO PC Thrice-daily

Intervention Type

Drug

Intervention Name(s)

Ferrous Fumarate

Intervention Description

Ferrous fumarate 200 mg PO PC

Primary Outcome Measure Information:

Title

Proportion of patient who achieved hemoglobin target

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events

Description

Incidence of Treatment-Emergent Adverse Events

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Songklanagarind Hospital

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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