Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism

Study Overview
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Brief Summary
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To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.

Detailed Description
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51 Patients presented to our university outpatient internal medicine clinic who are found to have iron deficiency anemia coexisting with subclinical hypothyroidism have been included in this study. Patients were randomly assigned to oral iron or oral iron plus levothyroxin therapy. The physician and the patients did not know who received oral iron only or oral iron plus levothyroxine treatment. Hematologic parameters as well as serum iron, ferritin and iron binding capacity were being measured at the beginning and 3 months after treatment in both groups.

Official Title
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Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study

Conditions
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Iron Deficiency Anemia, Subclinical Hypothyroidism

Intervention / Treatment
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* Drug: Ferrous sulfate tablets 325 mg, po, TID
* Drug: Ferrous sulfate plus levothyroxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism Must be able to swallow tablets Exclusion Criteria: Multifactorial anemia or anemia due to other reasons Iron deficiency anemia requiring urgent intervention- cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, Gİ, GU, etc. system Prior thyroid disorder and/or treatment history Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients | Drug: Ferrous sulfate tablets 325 mg, po, TID<br> <br> |
| Active Comparator: 2<br>Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients | Drug: Ferrous sulfate plus levothyroxine<br>* Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant improvement in Hgb and RBC |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, anemia, hypothyroidism, subclinical hypothyroidism