Vitamin D Plasma Level and Its Role in Headache

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Vitamin D Plasma Levels in the Development of Headache

Conditions
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Headache

Intervention / Treatment
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* Dietary Supplement: vitamin D supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients without headache. No drugs will be administered | |
| Experimental: Chronic Headache<br>Patients with headache > 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered. | Dietary Supplement: vitamin D supplementation<br>* In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.<br>|
| Experimental: Chronic headache with drug overuse<br>Patients with headache > 6 months related to drug treatment, i.e. non steroidal antinflammatory drugs. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered. | Dietary Supplement: vitamin D supplementation<br>* In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.<br>|
| Experimental: Acute Headache<br>Patients without chronic headache but with an history of headache < 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered. | Dietary Supplement: vitamin D supplementation<br>* In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of vitamin D using high performance liquid chromatography |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache pain through the Visual Analog Scale (VAS) |  | up to 24 weeks |