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临床试验/NCT00535561
NCT00535561已完成1 期

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

Duzce University1 个研究点 分布在 1 个国家开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
试验地点
1
主要终点
Significant improvement in Hgb and RBC

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
23 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism
  • Must be able to swallow tablets

排除标准

  • 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

研究组 & 干预措施

1

Active Comparator

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

干预措施: Ferrous sulfate tablets 325 mg, po, TID (Drug)

2

Active Comparator

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

干预措施: Ferrous sulfate plus levothyroxine (Drug)

结局指标

主要结局

Significant improvement in Hgb and RBC

时间窗: 3 months

次要结局

  • Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.(3 months)

研究者

发起方
Duzce University
申办方类型
Other

研究点 (1)

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