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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535561
• Other study ID #: 22-5
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2007
• Last updated: February 16, 2012
• Start date: June 2007
• Est. completion date: September 2007

Study information

• Verified date: February 2012
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethical Commitee for Duzce University School of Medicine Clinic and Laboratory Investigations
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 73 Years

Eligibility

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, GI, 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Hypothyroidism
• Iron Deficiency Anemia
• Subclinical Hypothyroidism

Intervention

Drug:
• Ferrous sulfate tablets 325 mg, po, TID

• Ferrous sulfate plus levothyroxine
Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID

Locations

Country	Name	City	State
Turkey	Duzce University School of Medicine	Duzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. Review. — View Citation

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. — View Citation

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

Kong WM, Sheikh MH, Lumb PJ, Naoumova RP, Freedman DB, Crook M, Doré 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 Oct 1;113(5):442. Naoumova P [corrected to Naoumova Rossitza P]. Am J Med 2002 Aug 15;113(3):264. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant improvement in Hgb and RBC		3 months
Secondary	Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.		3 months