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

February 16, 2012 updated by: Duzce University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Duzce, Turkey, 81620
        • Duzce University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant improvement in Hgb and RBC
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duzce University

Investigators

  • Study Director: Hakan Cinemre, Assit. Prof., Duzce University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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