We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D for Painful Nocturnal Leg Cramps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715429
Recruitment Status : Terminated (We exhausted potential candidates before reaching goal of 70; recruited 29, 13 completed the study)
First Posted : July 15, 2008
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Mayday Fund
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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, 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.

Condition or disease Intervention/treatment Phase
Leg Cramps, Nocturnal Drug: vitamin d Drug: placebo Not Applicable

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(OHD) 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 25-hydroxyvitamin 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 25-OHD 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).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in the Nocturnal Leg Cramp Rate [ Time Frame: 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 Outcome Measures :
  1. Serum Calcium Level [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715429


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Mayday Fund
Investigators
Layout table for investigator information
Principal Investigator: Mary E Elliott, PhD University of Wisconsin, Madison
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00715429    
Other Study ID Numbers: H-2007-0255
First Posted: July 15, 2008    Key Record Dates
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Leg cramps
vitamin D deficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Cramp
Spasm
Sleep-Wake Transition Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Parasomnias
 Sleep Wake Disorders
Mental Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents