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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00360074
Other study ID # FH 326/03
Secondary ID
Status Completed
Phase Phase 4
First received August 2, 2006
Last updated June 6, 2008
Start date February 2004
Est. completion date April 2007

Study information

Verified date June 2008
Source University Hospital Freiburg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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 1.1 µg/kg bw, which is below the average dose recommended in primary hypothyroidism (1.6 µg/kg 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 ± 0.05 μg/kg body weight (bw); "OPT-T4", optimized T4 treatment (1.6 μg/kg bw T4); "T3T4", combination of triiodothyronine (T3, 0.16) and T4 (1.44 μg/kg bw). Biochemical parameters, ankle reflex time and neurocognitive functions were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- history of cardiovascular or pulmonary diseases

- current thyroxin dosage > 1.6 µg/kg bw

- pregnancy

- epilepsy

- cerebrovascular diseases

- nodular goiter

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Thyroxin, Triiodothyronine


Locations

Country Name City State
Germany University Hospital Freiburg, Department of Medicine Freiburg Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & 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 thyro — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary well-being 3 weeks of treatment
Primary cognitive function 3 weeks of treatment
Secondary lipid metabolism 3 weeks of treatment
Secondary muscle function / ankle reflex time 3 weeks of treatment
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