HMG-CoA Reductase Inhibitors-related MyalgiasNCT01022398
Vitamin D Replacement: The Effect on Statin-Related Myalgias
A study of HMG-CoA Reductase Inhibitors-related Myalgias, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- HMG-CoA Reductase Inhibitors-related Myalgias
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)
- Patients aged 19-89 years old
- Men and women (not of childbearing potential)
- Patients receiving statins with concomitant ezetimibe
Who cannot join
- history of alcoholism or malnutrition
- receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cardiac Center at Creighton University
Omaha, Nebraska, 68131
About this study
The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.
- Being tested
- cholecalciferol/placebo
- Keywords
- Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol/placeboDrug
Also called Vitamin D3/placebo
10,000 IU by mouth weekly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly Receives: Drug: cholecalciferol/placebo |
| Placebo | Placebo comparator | Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly Receives: Drug: cholecalciferol/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Recruitment slow, funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HMG-CoA Reductase Inhibitors-related MyalgiasStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Schima, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022398
- Sponsor's protocol ID
- 09-15532
- Status last verified
- Sep 2012
- First submitted
- 27 Nov 2009
- Last updated
- 20 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Replacement: The Effect on Statin-Related Myalgias
- ClinicalTrials.gov ID
- NCT01022398
- Acronym / sponsor ID
- 09-15532
- Keywords
- Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slow, funding ended.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Posted 20 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: cholecalciferol/placeboSubjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly |
| Placebo | Placebo comparator | Drug: cholecalciferol/placeboSubjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)
- Patients aged 19-89 years old
- Men and women (not of childbearing potential)
- Patients receiving statins with concomitant ezetimibe
Key exclusion criteria (2 listed)
- history of alcoholism or malnutrition
- receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
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 |
|---|---|---|
| cholecalciferol/placeboAlso: Vitamin D3/placebo10,000 IU by mouth weekly for 6 months | Drug | Placebo, Vitamin D |
Primary outcome
Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Susan Schima, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of HMG-CoA Reductase Inhibitors-related Myalgias, run by Creighton University at 1 site in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 May 2013. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy (time frame: 6 months). 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 20 May 2013.