Aim of our study is to investigate the influence of HPT secondary to moderate-severe vitamin D deficiency and vitamin D replacement on the coagulation and fibrinolysis system
ID
Source
Brief title
Condition
- Other condition
- Parathyroid gland disorders
- Vitamin related disorders
Synonym
Health condition
cardiovasculaire aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following groups of lab markers will be tested:
- Overall test: vit. D level, PTH, serum calcium, phosphate, creatinin,
albumin, hsCRP
- Coagulation markers: von Willebrand factor and ristocetin activity, FVIII,
FVII, FIX, FX, FXI, fibrinogen, thrombin
- Natural anticoagulant inhibitors: antithrombin, protein C, protein S
- Fibrinolysis markers: t-PA, PAI-1, TAFI, D-dimer
Secondary outcome
nvt
Background summary
Endocrine disorders can influence the hemostatic balance. Abnormal coagulation
test results have been observed in patients with abnormal hormone levels. An
effect on markers of coagulation and fibrinolysis has been hypothesized also
for hyperparathyroidism (HPT). Primary HPT is associated with an increased
risk of cardiovascular (CV) morbidity and mortality. Many known CV risk
factors, such as hypertension, endothelial dysfunction, dyslipidemia, and
increased insulin resistance, have been reported in primary HPT. Few published
studies suggest increased levels of factor (F) VII, FX, D-dimer, tissue
plasminogen activator (t-PA) and plasminogen activator inhibitor (PAI)-1.
However, results are conflicting and several methodological drawbacks limit any
firm conclusion.
There is also evidence that vitamin D deficiency is an important CV risk factor
or indicator. Vitamin D deficiency is the most frequent cause of secondary
HPT. Therefore, HPT secondary to severe vitamin D deficiency is an optimal
clinical model to investigate the influence of parathyroid hormone (PTH) and
vitamin D replacement on the coagulation and fibrinolysis system.
Study objective
Aim of our study is to investigate the influence of HPT secondary to
moderate-severe vitamin D deficiency and vitamin D replacement on the
coagulation and fibrinolysis system
Study design
Prospective cohort study with a control group
Study burden and risks
At baseline and after 2 months, blood (30 ml) will be drawn out of a vein. The
treatment of the vitamin D deficiency will not be influenced.
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
Inclusion criteria
All consecutive adult patients with moderate-severe vitamin D deficiency, defined as blood levels of 25-OH-D less than 10 ng/ml (25 nmol/l). Controls: patients with vitamin D deficiency already on vitamin D suppletion with a normal PTH and vitamin D
Exclusion criteria
Pregnancy, acute and chronic renal disease, liver cirrhosis, granulomatosis, primary hyperparathyroidism, malabsorption syndromes, Von Willebrand disease, haemophilia, recent bariatric surgery (<13 months before vitamin D deficiency diagnosis)
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 | NL45045.048.13 |