Vitamin D Plasma Level and Its Role in Headache

NCT ID: NCT02467127

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-04-30

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Patients without headache. No drugs will be administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chronic Headache

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

Group Type: EXPERIMENTAL

vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.

Chronic headache with drug overuse

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.

Group Type: EXPERIMENTAL

vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.

Acute Headache

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.

Group Type: EXPERIMENTAL

vitamin D supplementation

Intervention Type: DIETARY_SUPPLEMENT

In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.

Interventions

vitamin D supplementation

In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Luca Gallelli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Gallelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Catanzaro

Locations

Pugliese Hospital

Catanzaro, , Italy

Countries

Italy

Other Identifiers

Headache 2015

Identifier Type: -

Identifier Source: org_study_id