Leg Cramps, Nocturnal Clinical Trial
Official title:
Nocturnal Leg Cramps in the Elderly: Randomized Controlled Trial of Ergocalciferol (Vitamin D2) for a Painful and Distressing Problem
| NCT number | NCT00715429 |
| Other study ID # | H-2007-0255 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2007 |
| Est. completion date | August 2011 |
| Verified date | August 2019 |
| Source | University of Wisconsin, Madison |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 persons
meeting preliminary (pre-lab) study criteria, two copies of the consent form will be
mailed, with the patient mailing back one signed consent to the PI.
| Status | Terminated |
| Enrollment | 29 |
| Est. completion date | August 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - One or more prescription for quinine at the Madison VA in the last 5 years, or else be a UWHC (U Wisconsin Health Clinics) patient whose UWHC medication list had quinine listed in the last five years - At least 50 years of age, with women being past menopause. This is defined as the woman reporting no periods in the last 12 consecutive months or longer. - Leg cramps listed in medical record, - Ability & willingness to give informed consent, - Stable estimated Glomerular filtration rate (GFR)>35 ml/min for the prior 6 mos, - No change in diuretic therapy in last 3 months, - Stable pattern of two or more cramps per week for past three months, - Ability to complete daily diary entry, - Post-consent: serum 25-OH of 20-45 ng/mL, albumin- corrected calcium <10.3 mg/dL, and urine calcium/creatinine ratio <0.25. Exclusion Criteria: - Not receiving primary care at Madison VAMC, or at UWHC - Hyperparathyroidism (1°, 2°, or 3°), - Osteomalacia , - Paget's disease, - Metastatic cancer, - Taking vitamin D 50,000 units capsules, - Serum Ca++ >10.3 mg/dL in subject chart, - Sarcoidosis or tuberculosis, and - Peripheral vascular disease or other condition confounding assessment of cramps. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Wisconsin | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Wisconsin, Madison | Mayday Fund |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the Nocturnal Leg Cramp Rate | 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. |
baseline and 77 day | |
| Secondary | Serum Calcium Level | 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. | Day 77 |