Trial Outcomes & Findings for Vitamin D Replacement: The Effect on Statin-Related Myalgias (NCT NCT01022398)

Last Updated: 2013-05-20

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

6 months

Results posted on

2013-05-20

Participant milestones
Measure	Vitamin D Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly	Placebo Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal
Measure	Vitamin D Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly	Placebo Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Overall Study Study terminated	2	2

Vitamin D Replacement: The Effect on Statin-Related Myalgias

Baseline characteristics by cohort
Measure	Vitamin D n=2 Participants Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly	Placebo n=2 Participants Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	49 years STANDARD_DEVIATION 1.4 • n=5 Participants	56.5 years STANDARD_DEVIATION 16.2 • n=7 Participants	52.75 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

Timeframe: 6 months

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Creighton University

Phone: 402-280-4566