Vitamin D Plasma Level and Its Role in Headache
VITDHEAD
The Role of Vitamin D Plasma Levels in the Development of Headache
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedSeptember 25, 2019
September 1, 2019
1.8 years
May 26, 2015
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma levels of vitamin D using high performance liquid chromatography
up to 24 weeks
Secondary Outcomes (1)
Headache pain through the Visual Analog Scale (VAS)
up to 24 weeks
Study Arms (4)
control group
NO INTERVENTIONPatients without headache. No drugs will be administered
Chronic Headache
EXPERIMENTALPatients with headache \> 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.
Chronic headache with drug overuse
EXPERIMENTALPatients 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.
Acute Headache
EXPERIMENTALPatients 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.
Interventions
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Eligibility Criteria
You may qualify if:
- acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pugliese Hospital
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Gallelli, MD
University of Catanzaro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 9, 2015
Study Start
November 1, 2015
Primary Completion
September 1, 2017
Study Completion
April 1, 2019
Last Updated
September 25, 2019
Record last verified: 2019-09