NCT01493648

Brief Summary

This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explored. Also, the investigators will assess the potential usefulness of vitamin D supplementation in a randomized control trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

November 29, 2011

Last Update Submit

January 26, 2016

Conditions

HMG COA Reductase Inhibitor Adverse Reaction

Keywords

statinsside effectsmusclevitamin Dbiopsystrengthfatigue

Outcome Measures

Primary Outcomes (2)

  • Change in pain score

    Change from baseline at 2 months

  • Change in muscle function testing

    Strenght and endurance evaluation

    Change from baseline at 2 months

Secondary Outcomes (4)

  • Change in muscle histology

    Change from baseline at 2 months

  • Change in pain score

    Change from baseline at 5 months

  • Change in muscle function testing

    Change from baseline at 5 months

  • Change in muscle histology

    Change from baseline at 5 months

Study Arms (2)

Vitamin D

EXPERIMENTAL
Drug: Vitamin D

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vitamin DDRUG

Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.

Also known as: Cholecalciferol, D-tabs
Vitamin D
PlaceboDRUG

Participants will receive placebo (lactose 100 mg) for 3 months.

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • statin therapy
  • healthy and sedentary or moderately physical active

You may not qualify if:

  • Current treatment with other lipid-lowering drugs
  • Natural medicine affecting lipid metabolism
  • CK levels above the normal range
  • Clinical vitamin D deficiency
  • Impaired liver or kidney function
  • Untreated hypo- or hyperthyroidism
  • Treatment with other medications known to increase risk of myopathy
  • Existing infection requiring antibiotic therapy
  • Consumption of greater than 60 ml of grapefruit juice per day
  • Inherited muscle disorders or myopathy
  • Polymyositis or inflammatory myopathy
  • Use of corticosteroids
  • Comorbidities resulting in muscle or bone pain
  • History of elevated CK
  • Unexplained cramps
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Québec - CHUL

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

  • Peyrel P, Mauriege P, Frenette J, Laflamme N, Greffard K, Dufresne SS, Huth C, Bergeron J, Joanisse DR. Impact of statin withdrawal on perceived and objective muscle function. PLoS One. 2023 Jun 14;18(6):e0281178. doi: 10.1371/journal.pone.0281178. eCollection 2023.

    PMID: 37315062DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Denis R Joanisse, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

  • Jean Bergeron, MD

    CHU de Quebec-Universite Laval

    PRINCIPAL INVESTIGATOR

  • Jérôme Frenette, PhD

    CHU de Quebec-Universite Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 16, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

CA(1)