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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04570475
Other study ID # HSC-MS-20-0945
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 15, 2021
Est. completion date May 13, 2024

Study information

Verified date May 2024
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study intends to investigate the use of high-dose Vitamin D3 plus a multivitamin in the prevention of cluster headache attacks. Participants can be enrolled anywhere in the United States that has access to one of our participating labs (for blood work - anticipated to be available in most of the USA). The study may include: - Screening: Participants may be interviewed, examined, fill out surveys, and get blood testing - Week 1: baseline period (no added medications - to establish a baseline) - Weeks 2-4: double-blinded experimental period - participants receive either 1) high-dose Vitamin D3 + multivitamin, or 2) placebo + multivitamin. Participants also fill out a survey and have blood testing. - Weeks 5-7: open-label period - ALL participants receive high-dose Vitamin D3 + multivitamin. Participants also fill out a survey and may have blood testing. Specifically, our primary outcome is the change from baseline to experimental weeks 1-3 in the frequency of cluster headache attacks between placebo and high-dose vitamin D. Specific primary and secondary outcomes are listed below.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date May 13, 2024
Est. primary completion date May 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - A diagnosis of episodic cluster headache according to the International Classification of Headache Disorders 3rd edition as well as cluster periods that are predictable and have a duration of 6 weeks or greater and approximately one attack daily minimum OR - A diagnosis of chronic cluster headache according to the International Classification of Headache Disorders 3rd edition as well as approximately one attack daily - Participants who are unlikely to need to change their preventive cluster headache treatment regimen in the next 6 weeks. Exclusion Criteria: - Co-existing disease or other characteristic that precludes appropriate diagnosis of cluster headache. - Active drug or alcohol use or dependence that, in the opinion of the site investigator,would interfere with adherence to study requirements. - Inability or unwillingness of subject to give informed consent. - Known allergy to study drug, multivitamin, or placebo components - Pregnancy or lactation (breastfeeding) - Usage of greater than 4,000 International Units of Vitamin D3 daily within 60 days of the beginning of the study. - Concurrent use of Vitamin D and/or multivitamin along with the inability to stop them before the study begins. - Liver failure or known coagulation disorder (as this study includes vitamin K) such as haemophilia, von Willebrand disease, Factor V Leiden, Antithrombin III deficiency, Protein C or S deficiency, or anti-phospholipid antibody syndrome. - A personal medical history of more than 1 deep venous thrombosis and/or pulmonary embolism (as this study includes vitamin K). - Current use of anticoagulants (as this study includes vitamin K). Anticoagulants include: apixaban (Eliquis), betrixaban (Bevyxxa), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, rivaroxiban (Xarelto), and warfarin (Coumadin). - Current use of medications that alter vitamin D metabolism, including steroids,interferon, phenytoin, phenobarbital, digitalis/digoxin, and thiazide diuretics (such as hydrochlorothiazide or chlorthalidone) - Participants who are aware that their most recent labwork in the last 2 years showed any of the following: 1. 25-hydroxyvitamin D levels >75 nmol/L 2. Elevated calcium level 3. Elevated phosphate level 4. Abnormal parathyroid hormone levels 5. Elevated creatinine level 6. Of note if any values are outside the acceptable range for the study, candidates may still participate in the study if the most recent lab testing is inside the acceptable range for the study. For example, if a candididate were taking a vitamin or medication that may have caused these elevated levels, but no longer take the vitamin or medication, they may be enrolled if retesting is normal.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vitamin D
Participants will receive vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.
multivitamin
Participants will receive placebo+multivitamin or vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.
Placebo
Participants will receive placebo+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in average weekly frequency of cluster headache attacks First primary outcome (baseline, average of weeks 1-3)
Primary Change in average weekly frequency of cluster headache attacks Second primary outcome (baseline, week 3)
Secondary Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 3 (baseline, week 3)
Secondary Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 3 baseline, week 3
Secondary Change in number of abortive medications or other treatments used per week baseline, week 3
Secondary Change in intensity of cluster headache attacks as assessed by numerical rating scale Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks baseline, week 3
Secondary Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past baseline, week 3
Secondary Change in quality of life as measured by the Cluster Headache Quality of life questionnaire Total score ranges from 0-100, and a higher score indicates a better quality of life baseline, week 3
Secondary Change in duration of cluster headache attacks, in minutes baseline, week 3
Secondary Change in level of 25-hydroxyvitamin D baseline, week 3
Secondary Change in average weekly frequency of cluster headache attacks (baseline, week 6)
Secondary Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 6 (baseline, week 6)
Secondary Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 6 baseline, week 6
Secondary Change in number of abortive medications or other treatments used per week baseline, week 6
Secondary Change in intensity of cluster headache attacks as assessed by numerical rating scale Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks baseline, week 6
Secondary Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past baseline, week 6
Secondary Change in quality of life as measured by the Cluster Headache Quality of life questionnaire Total score ranges from 0-100, and a higher score indicates a better quality of life baseline, week 6
Secondary Change in duration of cluster headache attacks, in minutes baseline, week 6
Secondary Change in level of 25-hydroxyvitamin D baseline, week 6
Secondary Number of days until end of the cluster period after the start of treatment (i.e., the time to the end of an episodic cluster cycle) upto 3 weeks from treatment
Secondary Change in average weekly frequency of cluster headache attacks (baseline, week 2)
Secondary Change in average weekly frequency of cluster headache attacks (baseline, week 1)
Secondary Change in intensity of cluster headache attacks as assessed by numerical rating scale Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks baseline, week 2
Secondary Change in intensity of cluster headache attacks as assessed by numerical rating scale Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks baseline, week 1
Secondary Change in duration of cluster headache attacks, in minutes baseline, week 2
Secondary Change in duration of cluster headache attacks, in minutes baseline, week 1
Secondary Change in number of abortive medications or other treatments used per week baseline, week 2
Secondary Change in number of abortive medications or other treatments used per week baseline, week 1
Secondary Change in quality of life as measured by the Cluster Headache Quality of life questionnaire Total score ranges from 0-100, and a higher score indicates a better quality of life baseline, week 2
Secondary Change in quality of life as measured by the Cluster Headache Quality of life questionnaire Total score ranges from 0-100, and a higher score indicates a better quality of life baseline, week 1
Secondary Change in level of 25-hydroxyvitamin D baseline, week 2
Secondary Change in level of 25-hydroxyvitamin D baseline, week 1
Secondary Change in level of calcium baseline, week 3
Secondary Change in level of calcium baseline, week 6
Secondary Change in level of calcium baseline, week 2
Secondary Change in level of calcium baseline, week 1
Secondary Change in level of phosphate baseline, week 3
Secondary Change in level of phosphate baseline, week 6
Secondary Change in level of phosphate baseline, week 1
Secondary Change in level of phosphate baseline, week 2
Secondary Change in level of parathyroid hormone baseline, week 3
Secondary Change in level of parathyroid hormone baseline, week 6
Secondary Change in level of parathyroid hormone baseline, week 1
Secondary Change in level of parathyroid hormone baseline, week 2
Secondary Change in level of creatinine baseline, week 3
Secondary Change in level of creatinine baseline, week 6
Secondary Change in level of creatinine baseline, week 1
Secondary Change in level of creatinine baseline, week 2
Secondary Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past baseline, week 2
Secondary Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past baseline, week 1
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