Primary objective:- To define the overall effect of oral Levothyroxine on coagulation parameters.Secondary objectives:- To define the specific effect of Levothyroxine on each tested coagulation parameters.- To define the specific effect of…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Coagulation and fibrinolytic parameters:
1) Prothrombin fragment 1+2 (F1+2)
2) Von Willebrand factor antigen (vWfAg)
3) D-dimer (ELISA assay)
4) Prothrombin time (PT)
5) Activated partial thromboplastin time (aPTT)
6) von Willebrand factor activity
7) factor VIII:C
8) Plasmin-antiplasmin complex (PAP)
9) Thrombin generation test (ETP)
Secondary outcome
Lipid parameters:
1) Total cholesterol
2) Low density lipoprotein (LDL)
3) High density lipoprotein (HDL)
4) Lipoprotein (a) (Lp(a))
5) Apolipoprotein A-I (Apo A-I)
6) Apolipoprotein B (Apo B)
7) CRP (C-Reactive protein)
Background summary
The link between the haemostatic system and thyroid disease has been
investigated since the beginning of the last century. Several mechanisms are
involved at different levels. Both thyroid dysfunction and autoimmunity may
modify physiological processes of primary and secondary haemostasis and lead to
bleeding or thrombosis. In particular, the influence on the coagulation system
is mainly mediated by the interaction between thyroid hormone and its
receptors.
In in vivo studies, several coagulation abnormalities have been reported in
patients with hypothyroidism and hyperthyroidism. Unfortunately, most published
studies on the relation between the coagulation system and thyroid hormones
have important methodological drawbacks. Lack of a control group, small study
size, heterogeneity of cause and of severity of thyroid dysfunction, and
different laboratory assays obscures the real in vivo effects of elevated and
decreased thyroid hormones on the hemostatic system.
To definitely define the overall in vivo effect of thyroid hormones on the
coagulation system, we plan this interventional trial on healthy volunteers.
Study objective
Primary objective:
- To define the overall effect of oral Levothyroxine on coagulation parameters.
Secondary objectives:
- To define the specific effect of Levothyroxine on each tested coagulation
parameters.
- To define the specific effect of Levothyroxine on each tested lipid
parameters.
Study design
Single blinded randomised controlled cross-over trial.
Intervention
Levothyroxine 0,3 mg per day for 14 days.
Study burden and risks
Burden associated with study participation:
- six hospital visits for blood sampling, minimal physical examination, ECG and
a short history of symptoms and signs.
- Use of study medication for 14 days.
Risks associated with participation:
The use of Levothyroxine can cause symptoms associated with (mild)
hyperthyroidism. There is a small risk of development of thyrotoxicosis with
cardiac arythmias. However, during each hospital visit (every 7 days) an ECG
will be made and any occuring signs and symptoms will be evaluated to check
heart frequency, heart rythm and the severity of hyperthyroidism. Because of
these frequent controls, any risks associated with the use of study medication
will be minimised.
Louwesweg 6
1066 EC Amsterdam
Nederland
Louwesweg 6
1066 EC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Adult >= 18 years and <= 40 years old.
- Informed consent.
Exclusion criteria
- Long term drug therapy including use or oral anticonceptive agents.
- Ongoing febrile, inflammatory, cardiovascular, renal, pulmonary, liver, neurological, endocrine, neoplastic diseases.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17151.048.07 |