Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360074
Status:
COMPLETED
Last Update Posted:
2008-06-09
First Post:
2006-08-02
Brief Title:
Phase 4 Study in Secondary Hypothyroidism Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
A Randomised Controlled Crossover Study Treatment With Thyroxin Compared to Thyroxin Triiodothyronin in Patients With Secondary Hypothyroidism
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Backround A normal thyroid function is critical for metabolism well-being and cognitive function It is now well accepted that primary subclinical hypothyroidism characterized by normal circulating thyroid hormones fT3 and fT4 and elevated TSH should be treated to improve reduced quality of life and abnormalities of lipid metabolism In central hypothyroidism CH the dose of replacement therapy aims to achieve normal thyroxin T4 concentrations as defined by appropriate reference populations Adequate thyroxin treatment is especially challenging as T4 cannot be titrated according to endogenous TSH levels because of the impaired hypothalamic-pituitary unit The majority of untreated CH patients show normal 40 or elevated TSH levels 35 while only a minority has reduced concentrations 25 Faglia 1979 1 These findings are explained by the lack of pulsatile secretion and nocturnal TSH surge which has been attributed to impaired thyrotroph function in CH patients Caron 1986 2 Moreover impaired biological activity of TSH itself due to reduced glycosylation has been described in secondary hypothyroidism
In a cross sectional study performed in patients with central hypothyroidism we found elevated cholesterol levels and increased ankle reflex time suggesting subtle hypothyroidism though fT3 and fT4 serum concentrations were within the normal range The average dose of thyroxin T4 applied in these patients with central hypothyroidism was 11 µgkg bw which is below the average dose recommended in primary hypothyroidism 16 µgkg bw We hypothesized that these results might indicate suboptimal T4 replacement therapy not detectable by current laboratory testing
Hypothesis To investigate the effects of a body weight adjusted T4 or T3T4 dose on metabolism well-being and cognitive function
Study design Placebo controlled trial in patients with central hypothyroidism following a double blind cross-over design
Intervention Three different treatment regimes 5 weeks each were compared CON-T4 empirically chosen current dose of T4 1 005 μgkg body weight bw OPT-T4 optimized T4 treatment 16 μgkg bw T4 T3T4 combination of triiodothyronine T3 016 and T4 144 μgkg bw Biochemical parameters ankle reflex time and neurocognitive functions were assessed
In a cross sectional study performed in patients with central hypothyroidism we found elevated cholesterol levels and increased ankle reflex time suggesting subtle hypothyroidism though fT3 and fT4 serum concentrations were within the normal range The average dose of thyroxin T4 applied in these patients with central hypothyroidism was 11 µgkg bw which is below the average dose recommended in primary hypothyroidism 16 µgkg bw We hypothesized that these results might indicate suboptimal T4 replacement therapy not detectable by current laboratory testing
Hypothesis To investigate the effects of a body weight adjusted T4 or T3T4 dose on metabolism well-being and cognitive function
Study design Placebo controlled trial in patients with central hypothyroidism following a double blind cross-over design
Intervention Three different treatment regimes 5 weeks each were compared CON-T4 empirically chosen current dose of T4 1 005 μgkg body weight bw OPT-T4 optimized T4 treatment 16 μgkg bw T4 T3T4 combination of triiodothyronine T3 016 and T4 144 μgkg bw Biochemical parameters ankle reflex time and neurocognitive functions were assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None