Quality of LifePhase 4T4-T3NCT00531713
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
A Phase 4 study testing Triiodothyronine in people with Quality of Life and Depression, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life, Depression
- What is being tested?
- Triiodothyronine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2003to Mar 2007
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.
Who cannot join
- <18 år
- >75 år
- pregnant women
- Thyroid cancer
- T3 treatment
- Post-partum thyroiditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy
Read the detailed description
double blind randomized cross-over study.
- Conditions
- Quality of Life, Depression
- Being tested
- Triiodothyronine
- Keywords
- hypothyroidism, quality og life, depression
- Medical subject headings
- Depression, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriiodothyronineDrug
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual T4 dose is given |
| 2 | Active comparator | 20 microgram of T3 is given and 50 microgram of T4 is withdrawn Receives: Drug: Triiodothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selv-rating scales: SF-36, SCL -90-R, BDI
Measured: 3 month treating
Secondary outcomes (1)
BMI, bioimpedance
Measured: 3 month treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startApr 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Birte Nygaard, Principal investigator, Herlev Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531713
- Sponsor's protocol ID
- T4-T3 hypothyreose
- Other IDs
- KA 02022ms
- Acronym
- T4-T3
- Status last verified
- Sep 2007
- First submitted
- 18 Sep 2007
- Last updated
- 19 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.
- ClinicalTrials.gov ID
- NCT00531713
- Acronym / sponsor ID
- T4-T3 / T4-T3 hypothyreose
- Conditions
- Quality of Life, Depression
- Keywords
- hypothyroidism, quality og life, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Mar 2007 (actual)
- First posted
- 19 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 compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy
Detailed description
double blind randomized cross-over study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual T4 dose is given |
| 2 | Active comparator | Drug: Triiodothyronine20 microgram of T3 is given and 50 microgram of T4 is withdrawn |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.
Key exclusion criteria (6 listed)
- <18 år
- >75 år
- pregnant women
- Thyroid cancer
- T3 treatment
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 |
|---|---|---|
| Triiodothyronine50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3 | Drug | 2 |
Primary outcome
Selv-rating scales: SF-36, SCL -90-R, BDI
Time frame: 3 month treating
1 secondary outcome
BMI, bioimpedance
Time frame: 3 month treament
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 19 Sep 2007.
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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.
Birte Nygaard principal investigator
Herlev Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triiodothyronine in people with Quality of Life and Depression, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 1 inclusion and 6 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 19 Sep 2007. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Selv-rating scales: SF-36, SCL -90-R, BDI (time frame: 3 month treating). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2007.