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Vitamin D Replacement in Statin-Induced Myopathy

Primary Purpose

HMG COA Reductase Inhibitor Adverse Reaction

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Vitamin D (Cholecalciferol )

Placebo

About this trial

This is an interventional treatment trial for HMG COA Reductase Inhibitor Adverse Reaction focused on measuring Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

male and female adults
identified by their physician as having myalgia with their statin medication.

Exclusion Criteria:

Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past.
Severe myositis
Consumption in excess of 14 alcoholic beverages per week
Situations which will cause difficulty in interpreting the vitamin D and / or PTH.

examples:

Present consumption of vitamin D supplements > 1000 iu daily
Renal impairment (Estimated creatinine clearance < 70 ± 14 mL/min/m2 in Males; and < 60 ± 10 mL/min/m2 in Females)
Chronic liver disease or impaired liver function
Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins

Sites / Locations

MUHC-Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D

Arm Description

Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study

Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3

Outcomes

Primary Outcome Measures

lack of need to stop statin medication due to myalgia

Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia

Secondary Outcome Measures

reduction of visual analog pain score

Full Information

NCT ID

NCT01400009

First Posted

July 20, 2011

Last Updated

April 6, 2015

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT01400009

Brief Title

Vitamin D Replacement in Statin-Induced Myopathy

Official Title

Vitamin D Replacement in Statin-Induced Myopathy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

lack of enrollment

Study Start Date

October 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.

Detailed Description

Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HMG COA Reductase Inhibitor Adverse Reaction

Keywords

Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study

Arm Title

Vitamin D

Arm Type

Active Comparator

Arm Description

Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3

Intervention Type

Drug

Intervention Name(s)

Vitamin D (Cholecalciferol )

Other Intervention Name(s)

DIN number 00821772

Intervention Description

10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Lactose 100 mg DIN 00501190

Intervention Description

Standard Placebo made of Lactose 100 mg

Primary Outcome Measure Information:

Title

lack of need to stop statin medication due to myalgia

Description

Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

reduction of visual analog pain score

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male and female adults identified by their physician as having myalgia with their statin medication. Exclusion Criteria: Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past. Severe myositis Consumption in excess of 14 alcoholic beverages per week Situations which will cause difficulty in interpreting the vitamin D and / or PTH. examples: Present consumption of vitamin D supplements > 1000 iu daily Renal impairment (Estimated creatinine clearance < 70 ± 14 mL/min/m2 in Males; and < 60 ± 10 mL/min/m2 in Females) Chronic liver disease or impaired liver function Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark H Sherman, MD,CM

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Study Chair

Facility Information:

Facility Name

MUHC-Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Replacement in Statin-Induced Myopathy

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