Iron Deficiency AnemiaPhase 1NCT00535561
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
A Phase 1 study testing Ferrous sulfate tablets 325 mg, po, TID and Ferrous sulfate plus levothyroxine in people with Iron Deficiency Anemia and Subclinical Hypothyroidism, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism. Read more about this study
- Who is it for?
- Ages 23 to 73 years
- Conditions the study is for
- Iron Deficiency Anemia, Subclinical Hypothyroidism
- What is being tested?
- Ferrous sulfate tablets 325 mg, po, TID and Ferrous sulfate plus levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2007to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism
- Must be able to swallow tablets
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University School of Medicine
Düzce, 81620
About this study
Official title: Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study
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.
- Conditions
- Iron Deficiency Anemia, Subclinical Hypothyroidism
- Being tested
- Ferrous sulfate tablets 325 mg, po, TID, Ferrous sulfate plus levothyroxine
- Keywords
- iron deficiency anemia, anemia, hypothyroidism, subclinical hypothyroidism
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate tablets 325 mg, po, TIDDrug
Ferrous sulfate plus levothyroxineDrug
Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients Receives: Drug: Ferrous sulfate tablets 325 mg, po, TID |
| 2 | Active comparator | Oral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients Receives: Drug: Ferrous sulfate plus levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant improvement in Hgb and RBC
Measured: 3 months
Secondary outcomes (1)
Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Investigators
- Hakan Cinemre, Assit. Prof., Study director, Duzce University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535561
- Sponsor's protocol ID
- 22-5
- Status last verified
- Feb 2012
- First submitted
- 25 Sep 2007
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11904108Surks 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 14722150Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.
PubMed 1257398Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. doi: 10.1056/NEJM200107263450406. No abstract available.
PubMed 11474665Gharib 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism: A Randomized, Double Blinded Study
- ClinicalTrials.gov ID
- NCT00535561
- Acronym / sponsor ID
- 22-5
- Conditions
- Iron Deficiency Anemia, Subclinical Hypothyroidism
- Keywords
- iron deficiency anemia, anemia, hypothyroidism, subclinical hypothyroidism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ferrous sulfate tablets 325 mg, po, TIDOral iron treatment only- for iron deficiency anemia and subclinical hypothyroidism coexisting patients |
| 2 | Active comparator | Drug: Ferrous sulfate plus levothyroxineOral iron plus levothyroxine treatment- for iron deficiency anemia and subclinical hypothyroidism coexisting patients |
Who may qualify
- Ages
- 23 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism
- Must be able to swallow tablets
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfate tablets 325 mg, po, TID | Drug | 1 |
| Ferrous sulfate plus levothyroxineCombination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID | Drug | 2 |
Primary outcome
Significant improvement in Hgb and RBC
Time frame: 3 months
1 secondary outcome
Significant improvement in serum iron, ferritin, TIBC and possibly in serum TSH and free T4 levels.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Background: PubMed 11904108Kong 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.
- Background: PubMed 14722150Surks 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.
- Background: PubMed 1257398Horton L, Coburn RJ, England JM, Himsworth RL. The haematology of hypothyroidism. Q J Med. 1976 Jan;45(177):101-23.
- Background: PubMed 11474665Cooper DS. Clinical practice. Subclinical hypothyroidism. N Engl J Med. 2001 Jul 26;345(4):260-5. doi: 10.1056/NEJM200107263450406. No abstract available.
- Background: PubMed 15643019Gharib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Cinemre, Assit. Prof. study director
Duzce University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferrous sulfate tablets 325 mg, po, TID and Ferrous sulfate plus levothyroxine in people with Iron Deficiency Anemia and Subclinical Hypothyroidism, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant improvement in Hgb and RBC (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535561, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.