Status:
TERMINATED
Vitamin D for Painful Nocturnal Leg Cramps
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Mayday Fund
Conditions:
Leg Cramps, Nocturnal
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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...
Detailed Description
This is a randomized, double-blind, placebo-controlled trial to determine if oral vitamin D administration reduces the number or severity of nocturnal leg cramps, compared to placebo. Symptom diaries ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00715429
Start Date
August 1 2007
End Date
August 1 2011
Last Update
September 17 2019
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705