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

Information source: Duzce University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Iron Deficiency Anemia; Subclinical Hypothyroidism

Intervention: Ferrous sulfate tablets 325 mg, po, TID (Drug); Ferrous sulfate plus levothyroxine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Duzce University

Official(s) and/or principal investigator(s):
Hakan Cinemre, Assit. Prof., Study Director, Affiliation: Duzce University School of Medicine

Summary

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

Clinical Details

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

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

Primary outcome: Significant improvement in Hgb and RBC

Secondary outcome: Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.

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

Minimum age: 23 Years. Maximum age: 73 Years. Gender(s): Both.

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

Locations and Contacts

Duzce University School of Medicine, Duzce 81620, Turkey
Additional Information

Related publications:

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.

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.

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.

Starting date: June 2007
Last updated: February 16, 2012

Page last updated: August 23, 2015

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