Clinical trial NCT00535561: Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
Official title: Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Subclinical Hypothyroidism
Keywords: iron deficiency anemia
anemia
hypothyroidism
subclinical hypothyroidism
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2007-09-26
Sex: ALL
Minimum age (years): 23
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Significant improvement in Hgb and RBC
timeFrame: 3 months
Secondary outcomes:
measure: Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.
timeFrame: 3 months
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University School of Medicine
Study officials:
affiliation: Duzce University School of Medicine
name: Hakan Cinemre, Assit. Prof.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/s0002-9343(02)01022-7.
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. doi: 10.1001/jama.291.2.228.
citation: Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.
citation: Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. doi: 10.1056/NEJM200107263450406. No abstract available.
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. doi: 10.1210/jc.2004-1231. No abstract available.