NCT00360074

Brief Summary

The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is superior to treatment guided by laboratory results of thyroxin hormones in patients with central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 9, 2008

Status Verified

June 1, 2008

First QC Date

August 2, 2006

Last Update Submit

June 6, 2008

Conditions

Secondary HypothyroidismHypopituitarismHyperlipidemias

Keywords

secondary hypothyroidismbody weight adjusted thyroxin dosetriiodothyronine supplementation

Outcome Measures

Primary Outcomes (2)

  • well-being

    3 weeks of treatment

  • cognitive function

    3 weeks of treatment

Secondary Outcomes (2)

  • lipid metabolism

    3 weeks of treatment

  • muscle function / ankle reflex time

    3 weeks of treatment

Interventions

Thyroxin, TriiodothyronineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency)
  • termination of surgical or radiation treatment of pituitary tumors at least six month before study entry
  • BMI of 20 - 39.9 kg/m2
  • non-smoking status.

You may not qualify if:

  • history of cardiovascular or pulmonary diseases
  • current thyroxin dosage \> 1.6 µg/kg bw
  • pregnancy
  • epilepsy
  • cerebrovascular diseases
  • nodular goiter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Freiburg, Department of Medicine

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Related Publications (1)

  • Slawik M, Klawitter B, Meiser E, Schories M, Zwermann O, Borm K, Peper M, Lubrich B, Hug MJ, Nauck M, Olschewski M, Beuschlein F, Reincke M. Thyroid hormone replacement for central hypothyroidism: a randomized controlled trial comparing two doses of thyroxine (T4) with a combination of T4 and triiodothyronine. J Clin Endocrinol Metab. 2007 Nov;92(11):4115-22. doi: 10.1210/jc.2007-0297. Epub 2007 Aug 21.

    PMID: 17711927RESULT

MeSH Terms

Conditions

HypothyroidismHypopituitarismHyperlipidemias

Interventions

ThyroxineTriiodothyronine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsThyronines

Study Officials

  • Prof Dr Martin Reincke, MD

    former Medical Professor of University Hospital Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 3, 2006

Study Start

February 1, 2004

Study Completion

April 1, 2007

Last Updated

June 9, 2008

Record last verified: 2008-06

Locations

DE(1)