Headache
Conditions
Brief summary
To date there are conflicting data concerning a correlation between plasma vitamin D levels and headache. The aim of this study was to evaluate plasma vitamin D levels in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.
Detailed description
Several papers suggest that inflammation is able to induces both headache and low levels of vitamin D. However, to date a correlation between plasma vitamin D levels and headache has not been demonstrated. Recently we documented that low levels of Vitamin D are related to a low statin efficacy. In this study we will evaluate the plasma levels of vitamin D in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital. Moreover it will be also evaluated: * the correlation between efficacy and safety of drugs used in headache treatment and plasma vitamin D levels. * the role of vitamin D supplementation on both headache symptoms and drug effects. Plasma vitamin D levels in patients with headache will be evaluated respect to patients without headache.
Interventions
DIETARY_SUPPLEMENTvitamin D supplementation
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Sponsors
University of Catanzaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association
Exclusion criteria
* allergy to drugs, * progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease) * renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values) * liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values) * alcohol consumption (\>3 alcoholic beverages daily) * substance abuse * inability to give written informed consent * actual or recent (3-month) treatment with corticosteroids, indomethacin or other antinflammatory drugs. * secondary headache
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of vitamin D using high performance liquid chromatography | up to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Headache pain through the Visual Analog Scale (VAS) | up to 24 weeks |
Countries
Italy
Outcome results
None listed