Vitamin D Plasma Level and Its Role in Headache

Headache Clinical Trial

— VITDHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467127
• Other study ID #: Headache 2015
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2019

Study information

• Verified date: September 2019
• Source: University of Cantanzaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

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

Locations

Country	Name	City	State
Italy	Pugliese Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Cantanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of vitamin D using high performance liquid chromatography		up to 24 weeks
Secondary	Headache pain through the Visual Analog Scale (VAS)		up to 24 weeks