Vitamin D for Painful Nocturnal Leg Cramps

NCT00715429 | Terminated Results DMC FDA Drug

• 1 other identifier: H-2007-0255
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 4.Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg cramps for subjects who receive it.
5. 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.

Conditions

Leg Cramps, Nocturnal

Keywords

Leg cramps; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum Calcium Level

  Day 77

Study Arms (2)

vitamin D 50,000 U/d x 10d, + vitamin D 50,000 U weekly 7 wks

EXPERIMENTAL

Vitamin D arm

Drug: vitamin d

placebo x 10d, + placebo weekly 7 wks

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

vitamin d DRUG

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.

Also known as: ergocalciferol

vitamin D 50,000 U/d x 10d, + vitamin D 50,000 U weekly 7 wks

placebo DRUG

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.

Also known as: lactose

placebo x 10d, + placebo weekly 7 wks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Mayday Fund: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Sleep-Wake Transition Disorders; Vitamin D Deficiency

Interventions

Vitamin D; Ergocalciferols; Lactose

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Limitations and Caveats

The enrollment was very small

Results Point of Contact

• Title: Dr. Mary Elliott
• Organization: University of Wisconsin School of Pharmacy

meelliott@pharmacy.wisc.edu

608-695-7501

Study Officials

• Mary E Elliott, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 17, 2019
• Results First Posted: September 17, 2019

Record last verified: 2019-08

Locations

US (1)