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

September 25, 2007
February 16, 2012
June 2007
Not Provided
Significant improvement in Hgb and RBC [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00535561 on ClinicalTrials.gov Archive Site
Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels. [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Iron Deficiency Anemia
  • Subclinical Hypothyroidism
  • Drug: Ferrous sulfate tablets 325 mg, po, TID
  • Drug: Ferrous sulfate plus levothyroxine
    Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
  • Active Comparator: 1
    Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients
    Intervention: 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
    Intervention: Drug: Ferrous sulfate plus levothyroxine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2007
Not Provided

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
Both
23 Years to 73 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00535561
22-5
No
Not Provided
Duzce University
Not Provided
Study Director: Hakan Cinemre, Assit. Prof. Duzce University School of Medicine
Duzce University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP