Trial record 5 of 104 for: hypothyroidism

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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

History of Changes

Purpose

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

Condition	Intervention	Phase
Iron Deficiency Anemia Subclinical Hypothyroidism	Drug: Ferrous sulfate tablets 325 mg, po, TID Drug: Ferrous sulfate plus levothyroxine	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron

Drug Information available for: Levothyroxine Levothyroxine sodium Ferrous sulfate Ferrous sulfate heptahydrate Sulfate ion

U.S. FDA Resources

Further study details as provided by Duzce University:

Primary Outcome Measures:

Significant improvement in Hgb and RBC [ Time Frame: 3 months ]

Secondary Outcome Measures:

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

Study Start Date:	June 2007
Study Completion Date:	September 2007

Arms	Assigned Interventions
Active Comparator: 1 Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients	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	Drug: Ferrous sulfate plus levothyroxine Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID

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

Ages Eligible for Study:	23 Years to 73 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535561

Locations

Turkey
Duzce University School of Medicine
Duzce, Turkey, 81620

Sponsors and Collaborators

Duzce University

Investigators

Study Director:

Hakan Cinemre, Assit. Prof.

Duzce University School of Medicine

More Information

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.

ClinicalTrials.gov Identifier:	NCT00535561 History of Changes
Other Study ID Numbers:	22-5
Study First Received:	September 25, 2007
Last Updated:	February 16, 2012
Health Authority:	Turkey: Ethical Commitee for Duzce University School of Medicine Clinic and Laboratory Investigations

Keywords provided by Duzce University:

iron deficiency anemia
anemia
hypothyroidism
subclinical hypothyroidism

Additional relevant MeSH terms:

Hypothyroidism
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Thyroid Diseases
Endocrine System Diseases
Malnutrition
Nutrition Disorders

Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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