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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-09-30

Brief Summary

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

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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.

Conditions

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Iron Deficiency Anemia Subclinical Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Group Type ACTIVE_COMPARATOR

Ferrous sulfate tablets 325 mg, po, TID

Intervention Type DRUG

2

Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Group Type ACTIVE_COMPARATOR

Ferrous sulfate plus levothyroxine

Intervention Type DRUG

Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID

Interventions

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Ferrous sulfate tablets 325 mg, po, TID

Intervention Type DRUG

Ferrous sulfate plus levothyroxine

Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID

Intervention Type DRUG

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

Minimum Eligible Age

23 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No