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

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

Date First Received: September 25, 2007

Last Updated: September 25, 2007

Verified by: Duzce University, September 2007

Clinical Trial Phase: Phase 1 | Start Date: June 2007

Overall Status: Completed

Brief Summary

Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment

Detailed Clinical Trial 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 levthyroine treatment. Hemotologic parameters as well as serum iron, ferritin and iron binding capacity were be measured at the beginning and 3 months after treatment in both groups.

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients
  • Active Comparator: 2
    • Oral iron plus levothyroine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Outcome Measures for this Clinical Trial

Primary Measures

  • Significant improvement in Hgb and RBC
    • Time Frame: 3 months

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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 subcli,nical hypothyroidism

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 23 Years

Maximum Age for this Clinical Trial: 73 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Duzce University

Overall Clinical Trial Officials and Contacts

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

Related Publications

References

Kong WM, Sheikh MH, Lumb PJ, Naoumova RP, Freedman DB, Crook M, Dore CJ, Finer N. A 6-month randomized trial of thyroxine treatment in women with mild subclinical hypothyroidism. Am J Med. 2002 Apr 1;112(5):348-54. Erratum in: Am J Med 2002 Aug 15;113(3):264. Am J Med 2002 Oct 1;113(5):442. Naoumova P [corrected to Naoumova Rossitza P].

Surks MI, Ortiz E, Daniels GH, Sawin CT, Col NF, Cobin RH, Franklyn JA, Hershman JM, Burman KD, Denke MA, Gorman C, Cooper RS, Weissman NJ. Subclinical thyroid disease: scientific review and guidelines for diagnosis and management. JAMA. 2004 Jan 14;291(2):228-38. Review.

Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.

Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. Review. No abstract available.

Gharib H, Tuttle RM, Baskin HJ, Fish LH, Singer PA, McDermott MT. Subclinical thyroid dysfunction: a joint statement on management from the American Association of Clinical Endocrinologists, the American Thyroid Association, and the Endocrine Society. J Clin Endocrinol Metab. 2005 Jan;90(1):581-5; discussion 586-7. No abstract available.

Additional Information

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535561

Study ID Number: 22-6

ClinicalTrials.gov Identifier: NCT00535561

Health Authority: Turkey: Ethical Commitee for Duzce University School of Medicine Clinic and Laboratory Investigations

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