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A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

Primary Purpose

Migraine According to International Headache Society (IHS) Criteria (ICHD-II)

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
D3 Vitamin ®
Placebo
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine According to International Headache Society (IHS) Criteria (ICHD-II) focused on measuring Migraine, Vitamin D

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • CCBR Aalborg A/S
  • Aalborg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Hypersensitivity
allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
Migraine Symptoms
Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
Quantitative Sensory Testing
Pain Pressure Threshold and temporal summation are measured.
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

Full Information

First Posted
September 25, 2012
Last Updated
December 28, 2015
Sponsor
Aalborg University
Collaborators
CCBR Aalborg A/S, Aalborg, Denmark, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01695460
Brief Title
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Official Title
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
CCBR Aalborg A/S, Aalborg, Denmark, Aalborg University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
Keywords
Migraine, Vitamin D

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
D3 Vitamin ®
Other Intervention Name(s)
D3 Vitamin ®, supplied by D3 Pharmacy Ltd
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
Primary Outcome Measure Information:
Title
The number of migraine attacks
Description
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).
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
Evaluation of pain during migraine attacks
Description
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.
Time Frame
every 4 weeks
Title
Hypersensitivity
Description
allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.
Time Frame
Baseline and every 4 weeks
Title
Migraine Symptoms
Description
Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.
Time Frame
every 4 weeks
Title
Quantitative Sensory Testing
Description
Pain Pressure Threshold and temporal summation are measured.
Time Frame
Every 4 weeks
Title
Measuring levels of a biomarker. Changes in the levels of these biomarkers.
Description
Changes in the levels of these biomarkers are measured: 25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2
Time Frame
Baseline and after 6 months treatment (end of trial)
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
HIT-6 (Headache Impact Test)
Time Frame
Every 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parisa Gazerani, Pharm D, PhD
Organizational Affiliation
Aalborg University
Official's Role
Study Chair
Facility Information:
Facility Name
CCBR Aalborg A/S
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30182753
Citation
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.
Results Reference
derived

Learn more about this trial

A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

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