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

This study has been completed.
Information provided by:
Duzce University Identifier:
First received: September 25, 2007
Last updated: February 16, 2012
Last verified: February 2012
To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.

Condition Intervention Phase
Iron Deficiency Anemia
Subclinical Hypothyroidism
Drug: Ferrous sulfate tablets 325 mg, po, TID
Drug: Ferrous sulfate plus levothyroxine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study

Resource links provided by NLM:

Further study details as provided by Duzce University:

Primary Outcome Measures:
  • Significant improvement in Hgb and RBC [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels. [ Time Frame: 3 months ]

Study Start Date: June 2007
Study Completion Date: September 2007
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   23 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00535561

Duzce University School of Medicine
Duzce, Turkey, 81620
Sponsors and Collaborators
Duzce University
Study Director: Hakan Cinemre, Assit. Prof. Duzce University School of Medicine
  More Information

Publications: Identifier: NCT00535561     History of Changes
Other Study ID Numbers: 22-5
Study First Received: September 25, 2007
Last Updated: February 16, 2012

Keywords provided by Duzce University:
iron deficiency anemia
subclinical hypothyroidism

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Thyroid Diseases
Endocrine System Diseases
Nutrition Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017