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Completed

NCT Number: NCT02467127

Vitamin D Plasma Level and Its Role in 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pugliese Hospital

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D Supplementation

Dietary Supplement

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

Primary outcomes

  1. Plasma levels of vitamin D using high performance liquid chromatography

    Time frame: up to 24 weeks

Secondary outcomes

  1. Headache pain through the Visual Analog Scale (VAS)

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Acronym: VITDHEAD

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jun 9, 2015
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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