Vitamin D Replacement in Statin-Induced Myopathy

NCT01400009 | Withdrawn

• 1 other identifier: D-STAT-2010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HMG COA Reductase Inhibitor Adverse Reaction

Keywords

Statin; HMG COA Reductase Inhibitor; myalgia; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• reduction of visual analog pain score

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Vitamin D

ACTIVE COMPARATOR

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

Drug: Vitamin D (Cholecalciferol )

Interventions

Vitamin D (Cholecalciferol ) DRUG

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

Also known as: DIN number 00821772

Vitamin D

Placebo DRUG

Standard Placebo made of Lactose 100 mg

Also known as: Lactose 100 mg DIN 00501190

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

MUHC-Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Myalgia

Interventions

Cholecalciferol; Lactose

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mark H Sherman, MD,CM

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Clinical), Dept of Medicine

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

CA (1)