Effect of T4-T3 Combination Therapy Versus T4 Monotherapy... | NCT00531713

Studies
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

NCT00531713

Sponsor

Copenhagen University Hospital at Herlev

Status

Completed

Last Update Posted

Sep 19, 2007Estimated

Enrollment

59Actual

Phase

Phase 4

Conditions

Quality of Life
Depression

Interventions

Triiodothyronine

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KA 02022ms

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Sep 18, 2007

First Submission Date that Met QC Criteria

Sep 18, 2007

First Posted Date

Sep 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2007

Last Update Posted Date

Sep 19, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Usual T4 dose is given
2	Active Comparator	20 microgram of T3 is given and 50 microgram of T4 is withdrawn	Drug: Triiodothyronine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triiodothyronine	Drug	50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3	2

Measure	Description	Time Frame
Selv-rating scales: SF-36, SCL -90-R, BDI		3 month treating

Measure	Description	Time Frame
BMI, bioimpedance		3 month treament

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

<18 år
>75 år
pregnant women
Thyroid cancer
T3 treatment
Post-partum thyroiditis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birte Nygaard	Herlev Trials	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of endocrinology , Herlev Hospital		Herlev	Herlev	dk-3650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D007037	Hypothyroidism

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014284	Triiodothyronine

Ancestor Terms

ID	Term
D013970	Thyronines
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided