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NCT00715429 · ClinicalTrials.gov registry record · NA
Vitamin D for Painful Nocturnal Leg Cramps
A NA study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT00715429 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 29 participants.
The verdict
NCT00715429, a NA study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study Summary
1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps? 2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison VA Medical Center(VAMC) or at the University of Wisconsin Hospitals and Clinics (UWHC). Individuals age 50 or more who have previously taken quinine for nocturnal leg cramps and meeting baseline criteria are eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin D levels, will undergo a 2-week "diary run-in" period to confirm cramp frequency. Those who report two or more leg cramps in each week will continue in the study and will be randomized to vitamin D or placebo. 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. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until a week after the last dose of study drug. Study investigators will call subjects at scheduled intervals to assess compliance, tolerability, and diary use. 3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and weakness. However, symptomatic hypercalcemia has not been reported except for those taking more than 40,000 units daily for several months. This is far above the cumulative dose in our study. 4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg cramps for subjects who receive it. 5. Consent Procedure: Flyers describing the study and telephone contact information will be mailed to patients who have received quinine during the period 2002-2007. The PI or Co-PI will return calls to describe the study and answer any questions. For p
Interventions
- DRUG placebo
- DRUG vitamin d
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00715429
The ClinicalTrials.gov registry entry for NCT00715429 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00715429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00715429 about?
NCT00715429 is a clinical study titled "Vitamin D for Painful Nocturnal Leg Cramps". 1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps? 2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison ...
What is the current status of trial NCT00715429?
This trial is currently terminated. It is a NA study. The enrollment target is 29 participants. The study started on 2007-08. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00715429?
The interventions under investigation include: placebo (DRUG), vitamin d (DRUG).
Who is sponsoring clinical trial NCT00715429?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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