Vitamin D for Painful Nocturnal Leg Cramps

• ClinicalTrials.gov Identifier: NCT00715429
• Recruitment Status: Terminated
• First Posted: July 15, 2008
• Results First Posted: September 17, 2019
• Last Update Posted: September 17, 2019
• Sponsor: University of Wisconsin, Madison
• Collaborator: Mayday Fund
• Information provided by (Responsible Party): University of Wisconsin, Madison

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Leg Cramps, Nocturnal
• Interventions: Drug: vitamin d; Drug: placebo
• Enrollment: 29

Participant Flow

Recruitment Details
Pre-assignment Details	15 participants got excluded from the study due to not fulfilling the inclusion criteria.

Arm/Group Title	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	Placebo x 10d, + Placebo Weekly 7 Wks
Arm/Group Description	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 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.
Period Title: Overall Study
Started	7	7
Completed	7	6
Not Completed	0	1
Reason Not Completed
Did not complete the study diary	0	1

Baseline Characteristics

Arm/Group Title		Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	Placebo x 10d, + Placebo Weekly 7 Wks	Total
Arm/Group Description		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 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 of all reporting groups
Overall Number of Baseline Participants		7	6	13
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	7 participants	6 participants	13 participants
		78; (64 to 87)	73; (62 to 79)	76; (62 to 87)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	7 participants	6 participants	13 participants
	Female	1 14.3%	1 16.7%	2 15.4%
	Male	6 85.7%	5 83.3%	11 84.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	7 participants	6 participants	13 participants
		7	6	13
Leg cramp frequency mean over 2 week prestudy [1]; Mean (Standard Deviation); Unit of measure: Cramps/day
	Number Analyzed	7 participants	6 participants	13 participants
		0.74 (0.56)	1.27 (1.15)	1.005 (0.855)
		[1] Measure Description: Eligibility requirements included having at least two cramps weekly.
25-hydroxyvitamin D concentration [1]; Mean (Standard Deviation); Unit of measure: Ng/ml
	Number Analyzed	7 participants	6 participants	13 participants
		38 (6)	34 (8)	37 (7)
		[1] Measure Description: Eligibility requirements included having 25-hydroxyvitamin D concentration between 20 and 45 ng/ml.
Serum calcium [1]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	7 participants	6 participants	13 participants
		9.0 (0.2)	9.1 (0.4)	9.05 (0.3)
		[1] Measure Description: Eligibility requirements included having normal serum calcium ranging from 8.5-10.2 mg/dL.
Urine calcium /creatinine ratio; Mean (Standard Deviation); Unit of measure: Ratio
	Number Analyzed	7 participants	6 participants	13 participants
		0.09 (0.10)	0.10 (0.08)	.095 (.09)
Estimated Glomerular Filtration Rate (eGFR); Mean (Standard Deviation); Unit of measure: Ml/min
	Number Analyzed	7 participants	6 participants	13 participants
		69 (19.6)	81 (25)	75 (22.3)

Outcome Measures

1. Primary Outcome

Title	Change in the Nocturnal Leg Cramp Rate
Description	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.
Time Frame	baseline and 77 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	7	6
Mean (Standard Deviation); Unit of Measure: cramps/day
	0.07 (0.28)	-0.05 (0.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.27
	Comments	Daily cramp rate at baseline& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.
	Method	t-test, 2 sided
	Comments	T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.

2. Secondary Outcome

Title	Serum Calcium Level
Description	Serum 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.
Time Frame	Day 77

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	7	6
Mean (Standard Deviation); Unit of Measure: mg/dL
	9.4 (0.3)	9.2 (0.4)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks		Placebo x 10d, + Placebo Weekly 7 Wks
Arm/Group Description	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 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.
All-Cause Mortality
	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks		Placebo x 10d, + Placebo Weekly 7 Wks
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious 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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0.00%)		0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks		Placebo x 10d, + Placebo Weekly 7 Wks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.86%)		5/6 (83.33%)
Blood and lymphatic system disorders
anemia † [1]	1/7 (14.29%)	1	0/6 (0.00%)	0
Endocrine disorders
hypoglycemia † [2]	1/7 (14.29%)	1	0/6 (0.00%)	0
Gastrointestinal disorders
gastroesophageal reflux † [3]	0/7 (0.00%)	0	1/6 (16.67%)	1
Musculoskeletal and connective tissue disorders
musculoskeletal pain † [4]	0/7 (0.00%)	0	2/6 (33.33%)	2
Psychiatric disorders
post traumatic stress disorder † [5]	0/7 (0.00%)	0	1/6 (16.67%)	1
Renal and urinary disorders
urinary tract infection †	0/7 (0.00%)	0	1/6 (16.67%)	1
Reproductive system and breast disorders
rise in PSA † [6]	1/7 (14.29%)	1	0/6 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] long term undiagnosed anemia, sees hematology clinic; [2] diabetic patient took too much insulin, dose was lowered; [3] patient given Prilosec for this; [4] arthritis pain, periodic; [5] temporary worsening of long standing ptsd from Vietnam experience; [6] patient had history of prostate cancer

Limitations and Caveats

The enrollment was very small

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Mary Elliott
• Organization: University of Wisconsin School of Pharmacy
• Phone: 608-695-7501
• EMail: meelliott@pharmacy.wisc.edu

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00715429
• Other Study ID Numbers: H-2007-0255
• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Results First Submitted: December 11, 2013
• Results First Posted: September 17, 2019
• Last Update Posted: September 17, 2019