CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Ergocalciferol +1 moredrug
Likely dose
Ergocalciferol 50,000IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01568255
NCT01568255Phase 4Completed

Is Treatment of Vitamin D Deficiency Associated With Resolution of Statin-Induced Muscular Symptoms

Cedars-Sinai Medical Center·interventional·Posted Apr 2, 2012·Updated Jun 10, 2021

In Brief

A Phase 4 clinical trial evaluating Ergocalciferol and Placebo for Myopathic Symptoms. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Statins are a class of drugs that are highly effective at lowering cholesterol levels. However, compliance is often limited by symptoms of muscle pain. The investigators would like to study Vitamin-D deficient individuals who also have muscle pain due to statin use. About 1 billion people are estimated to have low or insufficient levels of vitamin D worldwide. Patients with low or insufficient levels of vitamin D may develop muscle disease. The purpose of this study is to identify if these symptoms are associated with vitamin D deficiency, and most importantly, if treatment of vitamin D deficiency can reduce muscle pain that is caused by statin treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 14.3 years ago

Interventions

Ergocalciferoldrug

Ergocalciferol therapy at 50,000IU for 8 weeks

Placebodrug

placebo at 50,000IU for 8 weeks