Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-03-29 @ 3:49 PM
Study NCT ID:
NCT00535561
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2007-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-16', 'studyFirstSubmitDate': '2007-09-25', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant improvement in Hgb and RBC', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iron deficiency anemia', 'anemia', 'hypothyroidism', 'subclinical hypothyroidism'], 'conditions': ['Iron Deficiency Anemia', 'Subclinical Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '11904108', 'type': 'BACKGROUND', '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.'}, {'pmid': '14722150', 'type': 'BACKGROUND', '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.'}, {'pmid': '1257398', 'type': 'BACKGROUND', 'citation': 'Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.'}, {'pmid': '11474665', 'type': 'BACKGROUND', '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.'}, {'pmid': '15643019', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Multifactorial anemia or anemia due to other reasons\n* 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\n* Prior thyroid disorder and/or treatment history\n* 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'}, 'identificationModule': {'nctId': 'NCT00535561', 'briefTitle': 'Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study', 'orgStudyIdInfo': {'id': '22-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients', 'interventionNames': ['Drug: Ferrous sulfate tablets 325 mg, po, TID']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients', 'interventionNames': ['Drug: Ferrous sulfate plus levothyroxine']}], 'interventions': [{'name': 'Ferrous sulfate tablets 325 mg, po, TID', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Ferrous sulfate plus levothyroxine', 'type': 'DRUG', 'description': 'Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81620', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce University School of Medicine', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}], 'overallOfficials': [{'name': 'Hakan Cinemre, Assit. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duzce University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}}}}