Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
Information source: Duzce University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron Deficiency Anemia; Subclinical Hypothyroidism
Intervention: Ferrous sulfate (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: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment
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 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.
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 subcli,nical 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, 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.
Starting date: June 2007
Ending date: September 2007
Last updated: September 25, 2007
|
