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OpenTrials
Completed

NCT Number: NCT00535561

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

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

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Key information

Age range

23 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duzce University School of Medicine

Düzce, 81620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous sulfate tablets 325 mg, po, TID

Drug

Ferrous sulfate plus levothyroxine

Drug

Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID

Primary outcomes

  1. Significant improvement in Hgb and RBC

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study

Important dates

Study start
2007
Study completion
2007
First posted
Sep 26, 2007
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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