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

Primary Purpose

Iron Deficiency Anemia, Subclinical Hypothyroidism

Status
Completed
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Ferrous sulfate tablets 325 mg, po, TID
Ferrous sulfate plus levothyroxine
Sponsored by
Duzce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia, anemia, hypothyroidism, subclinical hypothyroidism

Eligibility Criteria

23 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duzce University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Outcomes

Primary Outcome Measures

Significant improvement in Hgb and RBC

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2007
Last Updated
February 16, 2012
Sponsor
Duzce University
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1. Study Identification

Unique Protocol Identification Number
NCT00535561
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duzce University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Subclinical Hypothyroidism
Keywords
iron deficiency anemia, anemia, hypothyroidism, subclinical hypothyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate tablets 325 mg, po, TID
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate plus levothyroxine
Intervention Description
Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
Primary Outcome Measure Information:
Title
Significant improvement in Hgb and RBC
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Cinemre, Assit. Prof.
Organizational Affiliation
Duzce University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Duzce University School of Medicine
City
Duzce
ZIP/Postal Code
81620
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
11904108
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. 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].
Results Reference
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PubMed Identifier
14722150
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.
Results Reference
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PubMed Identifier
1257398
Citation
Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.
Results Reference
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PubMed Identifier
11474665
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.
Results Reference
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PubMed Identifier
15643019
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.
Results Reference
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Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism

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