Vitamin D for Painful Nocturnal Leg Cramps

This study has been terminated.
(We exhausted potential candidates before reaching goal of 70; recruited 29, 29 completed the study)
Sponsor:
Collaborator:
Mayday Fund
Information provided by (Responsible Party):
Mary Elliott, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00715429
First received: July 10, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose
  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 or at the University of Wisconsin Hospitals and Clinics. 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.

Condition Intervention
Cramps
Drug: vitamin d
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nocturnal Leg Cramps in the Elderly: Randomized Controlled Trial of Ergocalciferol (Vitamin D2) for a Painful and Distressing Problem

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Frequency and severity of nocturnal leg cramps [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypercalcemia [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: August 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D 50,000 U/d x 10d, + vitamin D 50,000 U weekly 7 wks
Vitamin D arm
Drug: 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.
Other Name: ergocalciferol
Placebo Comparator: placebo x 10d, + placebo weekly 7 wks
placebo
Drug: 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.
Other Name: lactose

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 will be used throughout the study to assess frequency and severity of cramps. We will enroll a total of 70 men and women at least 50 years of age who have nocturnal leg cramps at least twice weekly and have previously received quinine for this. Those meeting baseline laboratory criteria and who report at least two leg cramps per week in a two-week "diary run-in" period will be randomized to vitamin D or placebo. Baseline, mid-study, and final laboratory testing will assess any changes in 25-hydroxyvitamin D and related variables (25-hydroxyvitamin D is the best measure of vitamin D status.) The time from the beginning of the diary run-in through the final dose of drug and last labs,will be about 14 weeks.

Optimal vitamin D status for health is unknown, although many experts aim for serum 25hydroxyvitamin D of 35-40 ng/ml. Subjects in this study randomized to vitamin D 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. Based on published literature on the ability of vitamin D to raise serum 25OHD over time, we estimate that the loading doses will "boost" levels after 10 days by an increment of ~40ng/ml (up to ~65 ng/mL total, starting with a typical person's baseline of 25ng/ml). This achieved level of 65 is within the reference range of our VA's reference range of 20-100. (In the PI's experience, most veterans without special D supplementation have baseline levels between 15 and 40).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715429

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Mayday Fund
Investigators
Principal Investigator: Mary E Elliott, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Mary Elliott, Associate Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00715429     History of Changes
Other Study ID Numbers: 2007-0255
Study First Received: July 10, 2008
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
leg cramps
vitamin D deficiency

Additional relevant MeSH terms:
Muscle Cramp
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 29, 2014