Trial Outcomes & Findings for Vitamin D for Painful Nocturnal Leg Cramps (NCT NCT00715429)
NCT ID: NCT00715429
Last Updated: 2019-09-17
Results Overview
Difference in number of leg cramps per day during treatment period compared to baseline period. Participants will undergo a 2-week "diary run-in" period to confirm cramp frequency. After a 2 week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until 1 week after the last dose of study drug/placebo.
TERMINATED
NA
29 participants
baseline and 77 day
2019-09-17
Participant Flow
15 participants got excluded from the study due to not fulfilling the inclusion criteria.
Participant milestones
| Measure |
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
Vitamin D arm
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo x 10d, + Placebo Weekly 7 Wks
placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
Vitamin D arm
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo x 10d, + Placebo Weekly 7 Wks
placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
|---|---|---|
|
Overall Study
Did not complete the study diary
|
0
|
1
|
Baseline Characteristics
Vitamin D for Painful Nocturnal Leg Cramps
Baseline characteristics by cohort
| Measure |
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
n=7 Participants
Vitamin D arm
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo x 10d, + Placebo Weekly 7 Wks
n=6 Participants
placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
73 years
n=7 Participants
|
76 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Leg cramp frequency mean over 2 week prestudy
|
0.74 cramps/day
STANDARD_DEVIATION 0.56 • n=5 Participants
|
1.27 cramps/day
STANDARD_DEVIATION 1.15 • n=7 Participants
|
1.005 cramps/day
STANDARD_DEVIATION 0.855 • n=5 Participants
|
|
25-hydroxyvitamin D concentration
|
38 ng/ml
STANDARD_DEVIATION 6 • n=5 Participants
|
34 ng/ml
STANDARD_DEVIATION 8 • n=7 Participants
|
37 ng/ml
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Serum calcium
|
9.0 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
9.1 mg/dL
STANDARD_DEVIATION 0.4 • n=7 Participants
|
9.05 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Urine calcium /creatinine ratio
|
0.09 ratio
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.10 ratio
STANDARD_DEVIATION 0.08 • n=7 Participants
|
.095 ratio
STANDARD_DEVIATION .09 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
69 ml/min
STANDARD_DEVIATION 19.6 • n=5 Participants
|
81 ml/min
STANDARD_DEVIATION 25 • n=7 Participants
|
75 ml/min
STANDARD_DEVIATION 22.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 77 dayDifference in number of leg cramps per day during treatment period compared to baseline period. Participants will undergo a 2-week "diary run-in" period to confirm cramp frequency. After a 2 week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until 1 week after the last dose of study drug/placebo.
Outcome measures
| Measure |
Vitamin D
n=7 Participants
Vitamin D
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo
n=6 Participants
Placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
|---|---|---|
|
Change in the Nocturnal Leg Cramp Rate
|
0.07 cramps/day
Standard Deviation 0.28
|
-0.05 cramps/day
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Day 77Serum calcium was measured to detect any possible correlation between high dose of Vitamin D and hypercalcemia. Hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL.
Outcome measures
| Measure |
Vitamin D
n=7 Participants
Vitamin D
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo
n=6 Participants
Placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
|---|---|---|
|
Serum Calcium Level
|
9.4 mg/dL
Standard Deviation 0.3
|
9.2 mg/dL
Standard Deviation 0.4
|
Adverse Events
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
Placebo x 10d, + Placebo Weekly 7 Wks
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
n=7 participants at risk
Vitamin D arm
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.
|
Placebo x 10d, + Placebo Weekly 7 Wks
n=6 participants at risk
placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.
|
|---|---|---|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Endocrine disorders
hypoglycemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
anemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
post traumatic stress disorder
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
rise in PSA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
Additional Information
Dr. Mary Elliott
University of Wisconsin School of Pharmacy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place