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

This study has been completed.
Sponsor:
Information provided by:
Duzce University
ClinicalTrials.gov Identifier:
NCT00535561
First received: September 25, 2007
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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 (Subject, Caregiver, 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.

  Eligibility

Ages Eligible for Study:   23 Years to 73 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535561

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

Publications:
ClinicalTrials.gov Identifier: NCT00535561     History of Changes
Other Study ID Numbers: 22-5
Study First Received: September 25, 2007
Last Updated: February 16, 2012
Health Authority: Turkey: Ethical Commitee for Duzce University School of Medicine Clinic and Laboratory Investigations

Keywords provided by Duzce University:
iron deficiency anemia
anemia
hypothyroidism
subclinical hypothyroidism

Additional relevant MeSH terms:
Hypothyroidism
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014