Vitamin D Plasma Level and Its Role in Headache (VITDHEAD)

University of Catanzaro

Status: Completed

Conditions: Headache

Treatments: Dietary Supplement: vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02467127

Headache 2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 4 patient groups

control group

No Intervention group

Description:

Patients without headache. No drugs will be administered

Chronic Headache

Experimental group

Description:

Patients with headache \> 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.

Treatment:

Dietary Supplement: vitamin D supplementation

Chronic headache with drug overuse

Experimental group

Description:

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.

Treatment:

Dietary Supplement: vitamin D supplementation

Acute Headache

Experimental group

Description:

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.

Treatment:

Dietary Supplement: vitamin D supplementation