Migraine According to International Headache Society (IHS) Criteria (ICHD-II)Phase 3NCT01695460
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
A Phase 3 study testing D3 Vitamin ® in people with Migraine According to International Headache Society (IHS) Criteria (ICHD-II), run by Aalborg University at 2 sites in Denmark.
Trial summary
The trial is primarily designed to investigate whether treatment with vitamin D may influence migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve as a prophylactic treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
- What is being tested?
- D3 Vitamin ®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2012to Dec 2015
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65, migraine must have occurred before the age of 50 years.
- Diagnosed migraine according to International Headache Society (IHS) criteria (ICHD-II)
Who cannot join
- Other neurological or neurodegenerative disorders
- Medical conditions that may interfere with the result - violent head trauma, stroke, transient ischemic attacks
- Musculoskeletal or mental illness
- Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs
- Inability to cooperate
- Pregnancy or breastfeeding, including women trying to conceive
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- Use of vitamin D supplementation> 10μg
- In treatment with digoxin or thiazide
- Patients with osteoarthritis, as they are taking or have taken vitamin D supplements
- Patients with pre-existing hypercalcemia as vitamin D supplements are contraindicated in these patients
Trial locations and contacts
2 sites in 1 country.
About this study
The trial is primarily designed to investigate whether treatment with vitamin D may influence migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means of quantitative sensory testing, diaries and blood samples for measurement of vitamin D. Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of those biomarkers will change following the treatment.
- Being tested
- D3 Vitamin ®, Placebo
- Keywords
- Migraine, Vitamin D
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3 Vitamin ®Drug
Also called D3 Vitamin ®, supplied by D3 Pharmacy Ltd
Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.
All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast.
PlaceboDrug
Also called Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.
The tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol.
D3 Vitamin ® consists of small white tablets, which are easy to swallow.
D3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units).
Tablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products. Receives: Drug: D3 Vitamin ® |
| Placebo | Placebo comparator | Placebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of migraine attacks
The primary endpoint is the frequency of migraine attacks. This is estimated from the subjects' listing of attacks in the form of diaries. This is assessed as the number of migraine attacks per 4 weeks (28 days).
Measured: every 4 weeks
Secondary outcomes (5)
Evaluation of pain during migraine attacks
Evaluation of pain during migraine attacks carried out by the subjects themselves by completing diaries. The diaries trial participants evaluate the pain intensity during an attack using a 1-3 scale, where 1 is mild pain, 2 is moderate pain, and 3 severe pain.
Measured: every 4 weeks
Hypersensitivity
allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
Measured: Baseline and every 4 weeks
Migraine Symptoms
Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
Measured: every 4 weeks
Quantitative Sensory Testing
Pain Pressure Threshold and temporal summation are measured.
Measured: Every 4 weeks
Measuring levels of a biomarker. Changes in the levels of these biomarkers.
Changes in the levels of these biomarkers are measured:
25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
Measured: Baseline and after 6 months treatment (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine According to International Headache Society (IHS) Criteria (ICHD-II)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- CCBR Aalborg A/S, Aalborg, Denmark, Aalborg University Hospital
- Responsible party
- Principal investigator, Parisa Gazerani, Aalborg University
- Investigators
- Parisa Gazerani, Pharm D, PhD, Study chair, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695460
- Sponsor's protocol ID
- N-20120052
- Other IDs
- Projekt #831302
- Status last verified
- Dec 2015
- First submitted
- 25 Sep 2012
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.
PubMed 30182753
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
- ClinicalTrials.gov ID
- NCT01695460
- Acronym / sponsor ID
- N-20120052
- Keywords
- Migraine, Vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- CCBR Aalborg A/S, Aalborg, Denmark, Aalborg University Hospital
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Sep 2012 (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.
The trial is primarily designed to investigate whether treatment with vitamin D may influence migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means of quantitative sensory testing, diaries and blood samples for measurement of vitamin D. Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of those biomarkers will change following the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: D3 Vitamin ®The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg. The tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol. D3 Vitamin ® consists of small white tablets, which are easy to swallow. D3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units). Tablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between 18 and 65, migraine must have occurred before the age of 50 years.
- Diagnosed migraine according to International Headache Society (IHS) criteria (ICHD-II)
Key exclusion criteria (10 listed)
- Other neurological or neurodegenerative disorders
- Medical conditions that may interfere with the result - violent head trauma, stroke, transient ischemic attacks
- Musculoskeletal or mental illness
- Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs
- Inability to cooperate
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 |
|---|---|---|
| D3 Vitamin ®Also: D3 Vitamin ®, supplied by D3 Pharmacy LtdVitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment. All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast. | Drug | Vitamin D |
| PlaceboAlso: Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd | Drug | Placebo |
Primary outcome
The number of migraine attacks
Time frame: every 4 weeks
The primary endpoint is the frequency of migraine attacks. This is estimated from the subjects' listing of attacks in the form of diaries. This is assessed as the number of migraine attacks per 4 weeks (28 days).
5 secondary outcomes
Evaluation of pain during migraine attacks
Time frame: every 4 weeks
Hypersensitivity
Time frame: Baseline and every 4 weeks
Migraine Symptoms
Time frame: every 4 weeks
Quantitative Sensory Testing
Time frame: Every 4 weeks
Measuring levels of a biomarker. Changes in the levels of these biomarkers.
Time frame: Baseline and after 6 months treatment (end of trial)
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 29 Dec 2015.
- Derived from this study: PubMed 30182753Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.
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.
Parisa Gazerani, Pharm D, PhD study chair
Aalborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D3 Vitamin ® in people with Migraine According to International Headache Society (IHS) Criteria (ICHD-II), run by Aalborg University at 2 sites in Denmark.
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 2 inclusion and 10 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of migraine attacks (time frame: every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695460, which also lists 1 linked publication.
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 29 Dec 2015.