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CompletedNCT00535561Updated Feb 17, 2012

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

A Phase 1 interventional study of Ferrous sulfate tablets 325 mg, po, TID and Ferrous sulfate plus levothyroxine in Iron Deficiency Anemia and Subclinical Hypothyroidism, sponsored by Duzce University. Completed at 1 site in Turkey. Open to participants aged 23 Years to 73 Years. Per ClinicalTrials.gov, last updated 2012-02-17.

Sponsored by Duzce University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
23 Years to 73 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Iron Deficiency Anemia
  • Subclinical Hypothyroidism

Keywords

  • iron deficiency anemia
  • anemia
  • hypothyroidism
  • subclinical hypothyroidism
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

Browse Anemia studies →

Lead sponsor

Duzce University is the lead sponsor of 70 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 73 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)

Study arms

  • Active comparator
    1

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

    Drug: Ferrous sulfate tablets 325 mg, po, TID

  • Active comparator
    2

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

    Drug: Ferrous sulfate plus levothyroxine

Interventions

  • DrugFerrous sulfate tablets 325 mg, po, TID
  • DrugFerrous sulfate plus levothyroxine

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

06

What researchers measure

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

07

Study locations

1 site
  • Duzce University School of Medicine
    Duzce, 81620, Turkey
08

References and documents

Publications

  • 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]. PubMed 11904108 ↗
  • 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. PubMed 14722150 ↗
  • Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23. PubMed 1257398 ↗
  • Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. doi: 10.1056/NEJM200107263450406. No abstract available. PubMed 11474665 ↗
  • 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. PubMed 15643019 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00535561
Lead sponsor
Duzce University
First posted
Sep 26, 2007
Start date
Jun 2007
Completion
Sep 2007
Last update
Feb 17, 2012

Study contacts

Hakan Cinemre, Assit. Prof.
study director · Duzce University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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