Trial · NCT00715429

Vitamin D for Painful Nocturnal Leg Cramps

NCT00715429, Not applicable, Terminated, University of Wisconsin, Madison; results first posted 2019-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin D for Painful Nocturnal Leg Cramps. Trials, record NCT00715429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00715429

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vitamin D for Painful Nocturnal Leg Cramps
NCT number: NCT00715429
Status: Terminated
Phases: Not applicable
Enrollment: 29 participants, actual
Lead sponsor: University of Wisconsin, Madison
Conditions: Leg Cramps, Nocturnal
Interventions: vitamin d, placebo
First posted: 2008-07-15
Last updated: 2019-09-17
Results first posted: 2019-09-17
Limitations and caveats: The enrollment was very small

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in the Nocturnal Leg Cramp Rate	baseline and 77 day	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.
Secondary	Serum Calcium Level	Day 77	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in the Nocturnal Leg Cramp Rate	baseline and 77 day		cramps/day	MEAN
SECONDARY	Serum Calcium Level	Day 77		mg/dL	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in the Nocturnal Leg Cramp Rate	Vitamin D	0.07	Standard Deviation 0.28	cramps/day
Change in the Nocturnal Leg Cramp Rate	Placebo	-0.05	Standard Deviation 0.35	cramps/day
Serum Calcium Level	Vitamin D	9.4	Standard Deviation 0.3	mg/dL
Serum Calcium Level	Placebo	9.2	Standard Deviation 0.4	mg/dL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	7
Overall Study	STARTED	Placebo x 10d, + Placebo Weekly 7 Wks	7
Overall Study	COMPLETED	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	7
Overall Study	COMPLETED	Placebo x 10d, + Placebo Weekly 7 Wks	6
Overall Study	NOT COMPLETED	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	0
Overall Study	NOT COMPLETED	Placebo x 10d, + Placebo Weekly 7 Wks	1

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	urinary tract infection	Renal and urinary disorders	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	0	7	0
other	urinary tract infection	Renal and urinary disorders	Placebo x 10d, + Placebo Weekly 7 Wks	1	6	1
other	hypoglycemia	Endocrine disorders	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	1	7	1
other	hypoglycemia	Endocrine disorders	Placebo x 10d, + Placebo Weekly 7 Wks	0	6	0
other	anemia	Blood and lymphatic system disorders	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	1	7	1
other	anemia	Blood and lymphatic system disorders	Placebo x 10d, + Placebo Weekly 7 Wks	0	6	0
other	post traumatic stress disorder	Psychiatric disorders	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	0	7	0
other	post traumatic stress disorder	Psychiatric disorders	Placebo x 10d, + Placebo Weekly 7 Wks	1	6	1
other	rise in PSA	Reproductive system and breast disorders	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	1	7	1
other	rise in PSA	Reproductive system and breast disorders	Placebo x 10d, + Placebo Weekly 7 Wks	0	6	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks
Total, all-cause mortality	Placebo x 10d, + Placebo Weekly 7 Wks
Total, other adverse events	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	3	7
Total, other adverse events	Placebo x 10d, + Placebo Weekly 7 Wks	5	6
Total, serious adverse events	Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks	0	7
Total, serious adverse events	Placebo x 10d, + Placebo Weekly 7 Wks	0	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks vs Placebo x 10d, + Placebo Weekly 7 Wks: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00715429

GET https://conductscience.org/api/trials/v1/NCT00715429/registered

API reference For AI assistants