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

Phase 1

Completed

• Conditions: Iron Deficiency Anemia; Subclinical Hypothyroidism
• Interventions: Drug: Ferrous sulfate tablets 325 mg, po, TID; Drug: Ferrous sulfate plus levothyroxine

• Registration Number: NCT00535561
• Lead Sponsor: Duzce University

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.

Study Timeline

• Study Start: 2007-06
• Study Completion: 2007-09
• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ferrous sulfate tablets 325 mg, po, TID	Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients
2	Ferrous sulfate plus levothyroxine	Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients

Primary Outcome Measures

Name	Time	Method
Significant improvement in Hgb and RBC	3 months

Secondary Outcome Measures

Name	Time	Method
Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.	3 months

Trial Locations

Locations (1)

Duzce University School of Medicine; 🇹🇷 Duzce, Turkey