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

Study Overview
=================
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.

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

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Ferrous Fumarate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrice-weekly group<br>Ferrous fumarate 200 mg PO PC Thrice-weekly | Drug: Ferrous Fumarate<br>* Ferrous fumarate 200 mg PO PC<br>|
| Active Comparator: Thrice-daily group<br>Ferrous fumarate 200 mg PO PC Thrice-daily | Drug: Ferrous Fumarate<br>* Ferrous fumarate 200 mg PO PC<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ferrous fumarate, oral iron treatment, thrice-weekly, thrice-daily, iron deficiency anemia