HMG-CoA Reductase Inhibitors-related Myalgias
Conditions
Keywords
Vitamin D3, HMG-CoA reductase inhibitors (statin)-related myalgias
Brief 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.
Interventions
DRUGcholecalciferol/placebo
10,000 IU by mouth weekly for 6 months
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* history of alcoholism or malnutrition * receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly | 2 |
| Placebo Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Vitamin D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age Continuous | 56.5 years STANDARD_DEVIATION 16.2 | 49 years STANDARD_DEVIATION 1.4 | 52.75 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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