Trial Outcomes & Findings for Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms (NCT NCT01568255)
NCT ID: NCT01568255
Last Updated: 2021-06-10
Results Overview
To investigate if Vitamin D therapy reduces myopathic pain in subjects on statin medication who have low vitamin D levels and experience myopathic pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
Vitamin D Treatment
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5/6 placebo participants provided an answer to history of diabetes. 1/6 placebo participants did not provide an answer to history of diabetes
Baseline characteristics by cohort
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=6 Participants
|
11 participants
n=11 Participants
|
|
History of Diabetes
|
2 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of diabetes. 1/6 placebo participants did not provide an answer to history of diabetes
|
2 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of diabetes. 1/6 placebo participants did not provide an answer to history of diabetes
|
4 Participants
n=10 Participants • 5/6 placebo participants provided an answer to history of diabetes. 1/6 placebo participants did not provide an answer to history of diabetes
|
|
History of High Cholesterol
|
4 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of high cholesterol. 1/6 placebo participants did not provide an answer to history of high cholesterol
|
3 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of high cholesterol. 1/6 placebo participants did not provide an answer to history of high cholesterol
|
7 Participants
n=10 Participants • 5/6 placebo participants provided an answer to history of high cholesterol. 1/6 placebo participants did not provide an answer to history of high cholesterol
|
|
History of High Blood Pressure
|
3 Participants
n=5 Participants • 5/6 placebo participants provided an answer to a history of high blood pressure. 1/6 participants did not provide an answer to a history of high blood pressure
|
1 Participants
n=5 Participants • 5/6 placebo participants provided an answer to a history of high blood pressure. 1/6 participants did not provide an answer to a history of high blood pressure
|
4 Participants
n=10 Participants • 5/6 placebo participants provided an answer to a history of high blood pressure. 1/6 participants did not provide an answer to a history of high blood pressure
|
|
History of High Triglyceride
|
2 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of high triglycerides. 1/6 placebo participants did not provide an answer to a history of high triglycerides
|
2 Participants
n=5 Participants • 5/6 placebo participants provided an answer to history of high triglycerides. 1/6 placebo participants did not provide an answer to a history of high triglycerides
|
4 Participants
n=10 Participants • 5/6 placebo participants provided an answer to history of high triglycerides. 1/6 placebo participants did not provide an answer to a history of high triglycerides
|
|
Family History of Coronary Heart Disease
|
2 Participants
n=4 Participants • 4/5 Vitamin D participants provided an answer to family history of coronary heart disease. 4/5 Vitamin D participants did not provide an answer to family history of coronary heart disease. 4/6 placebo participants provided an answer to family history of coronary heart disease. 2/6 placebo participants did not provide an answer to family history of coronary heart disease.
|
3 Participants
n=4 Participants • 4/5 Vitamin D participants provided an answer to family history of coronary heart disease. 4/5 Vitamin D participants did not provide an answer to family history of coronary heart disease. 4/6 placebo participants provided an answer to family history of coronary heart disease. 2/6 placebo participants did not provide an answer to family history of coronary heart disease.
|
5 Participants
n=8 Participants • 4/5 Vitamin D participants provided an answer to family history of coronary heart disease. 4/5 Vitamin D participants did not provide an answer to family history of coronary heart disease. 4/6 placebo participants provided an answer to family history of coronary heart disease. 2/6 placebo participants did not provide an answer to family history of coronary heart disease.
|
PRIMARY outcome
Timeframe: 8 weeksTo investigate if Vitamin D therapy reduces myopathic pain in subjects on statin medication who have low vitamin D levels and experience myopathic pain.
Outcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Number of Participants With Reduction in Myopathic Pain
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksBrief Pain Inventory (BPI) severity and interference questionnaires. BPI Severity Scale from 0 (Low Pain) to 10 (High Pain).
Outcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Brief Pain Inventory (BPI) Severity at Exit
|
4.5625 score on a scale
Standard Deviation 2.6877
|
3.8125 score on a scale
Standard Deviation 2.4612
|
PRIMARY outcome
Timeframe: 8 weeksAssessed with serum measurements
Outcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Vitamin 25 OH D Levels
|
18.075 ng/mL
Standard Deviation 4.537
|
18.05 ng/mL
Standard Deviation 6.251
|
PRIMARY outcome
Timeframe: 8 weeksBrief Pain Inventory (BPI) severity and interference questionnaires. BPI Severity on a scale from 1 (Low Interference) to 10 (High Interference).
Outcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Brief Pain Inventory (BPI) Interference at Exit
|
3.85714285725 score on a scale
Standard Deviation 1.97948663699
|
0.80952380967 score on a scale
Standard Deviation 1.28041234868
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Lipid Profile - Total Cholesterol Levels
|
165.8 mg/dl
Standard Deviation 37.89
|
197.67 mg/dl
Standard Deviation 65.68
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Lipid Profile - LDL Cholesterol Levels
|
88.4 mg/dl
Standard Deviation 28.64
|
106.83 mg/dl
Standard Deviation 55.33
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Lipid Profile - HDL Cholesterol Levels
|
51.8 mg/dl
Standard Deviation 5.72
|
63.5 mg/dl
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Vitamin D Treatment
n=5 Participants
Vitamin D Treatment Group
Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks
|
Placebo Group
n=6 Participants
Placebo at 50,000IU for 8 weeks
Placebo: placebo at 50,000IU for 8 weeks
|
|---|---|---|
|
Lipid Profile - Triglycerides Levels
|
107.54 mg/dl
Standard Deviation 0.8943
|
86.92 mg/dl
Standard Deviation 128
|
Adverse Events
Vitamin D Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place