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

September 24, 2019 updated by: Luca Gallelli, University of Catanzaro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Pugliese Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Patients without headache. No drugs will be administered
Experimental: Chronic Headache
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
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Experimental: 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.
Dietary supplement: vitamin D supplementation
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Experimental: 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.
Dietary supplement: vitamin D supplementation
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Investigators

  • Principal Investigator: Luca Gallelli, MD, University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Headache 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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