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

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
vitamin D supplementation
Sponsored by
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Pugliese Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

control group

Chronic Headache

Chronic headache with drug overuse

Acute Headache

Arm Description

Patients without headache. No drugs will be administered

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

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.

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.

Outcomes

Primary Outcome Measures

Plasma levels of vitamin D using high performance liquid chromatography

Secondary Outcome Measures

Headache pain through the Visual Analog Scale (VAS)

Full Information

First Posted
May 26, 2015
Last Updated
September 24, 2019
Sponsor
University of Catanzaro
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1. Study Identification

Unique Protocol Identification Number
NCT02467127
Brief Title
Vitamin D Plasma Level and Its Role in Headache
Acronym
VITDHEAD
Official Title
The Role of Vitamin D Plasma Levels in the Development of Headache
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients without headache. No drugs will be administered
Arm Title
Chronic Headache
Arm Type
Experimental
Arm Description
Patients with headache > 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.
Arm Title
Chronic headache with drug overuse
Arm Type
Experimental
Arm 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.
Arm Title
Acute Headache
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D supplementation
Intervention Description
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Primary Outcome Measure Information:
Title
Plasma levels of vitamin D using high performance liquid chromatography
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Headache pain through the Visual Analog Scale (VAS)
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Gallelli, MD
Organizational Affiliation
University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pugliese Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

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