HeadacheVITDHEADNCT02467127
Vitamin D Plasma Level and Its Role in Headache
A study testing vitamin D supplementation in people with Headache, run by University of Catanzaro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- vitamin D supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association
Who cannot join
- 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
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- inability to give written informed consent
- actual or recent (3-month) treatment with corticosteroids, indomethacin or other antinflammatory drugs.
- secondary headache
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache
- Being tested
- vitamin D supplementation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplementationDietary supplement
In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients without headache. No drugs will be administered |
| Chronic Headache | Experimental | Patients with headache > 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered. Receives: Dietary Supplement: vitamin D supplementation |
| Chronic headache with drug overuse | Experimental | 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. Receives: Dietary Supplement: vitamin D supplementation |
| Acute Headache | Experimental | 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. Receives: Dietary Supplement: vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of vitamin D using high performance liquid chromatography
Measured: up to 24 weeks
Secondary outcomes (1)
Headache pain through the Visual Analog Scale (VAS)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
- Investigators
- Luca Gallelli, MD, Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467127
- Sponsor's protocol ID
- Headache 2015
- Acronym
- VITDHEAD
- Status last verified
- Sep 2019
- First submitted
- 26 May 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin D Plasma Levels in the Development of Headache
- ClinicalTrials.gov ID
- NCT02467127
- Acronym / sponsor ID
- VITDHEAD / Headache 2015
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients without headache. No drugs will be administered |
| Chronic Headache | Experimental | Dietary Supplement: vitamin D supplementationPatients with headache > 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered. |
| Chronic headache with drug overuse | Experimental | Dietary Supplement: vitamin D supplementationPatients 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 | Experimental | Dietary Supplement: vitamin D supplementationPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D supplementationIn patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation. | Dietary supplement | Acute Headache, Chronic Headache, Chronic headache with drug overuse |
Primary outcome
Plasma levels of vitamin D using high performance liquid chromatography
Time frame: up to 24 weeks
1 secondary outcome
Headache pain through the Visual Analog Scale (VAS)
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Gallelli, MD principal investigator
University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D supplementation in people with Headache, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of vitamin D using high performance liquid chromatography (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.