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Vitamin Supplement
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates (VitD Trial)
Charlotte, NC
N/A
Waitlist Available
Led By Madhav Karunakar, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Summary
The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.
See full description
Eligible Conditions
- Rickets
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fracture Non-union
Fracture Union
Secondary study objectives
Deep Infection
Fixation Failure
Lost to Follow-up
Side effects data
From 2016 Phase 4 trial • 1366 Patients • NCT0170911012%
Back pain
7%
Arthralgia
3%
Fall
1%
Hip fracture
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vitamin DExperimental Treatment1 Intervention
Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.
Group II: NormovitaminosisActive Control1 Intervention
Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.
Group III: PlaceboPlacebo Group1 Intervention
Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3630
Find a Location
Closest Location:Carolinas Medical Center· Charlotte, NC
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,417 Previous Clinical Trials
2,499,832 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,809 Total Patients Enrolled
Christine Churchill, MAStudy ChairWake Forest University Health Sciences
Rachel Seymour, PhDStudy DirectorWake Forest University Health Sciences
4 Previous Clinical Trials
1,650 Total Patients Enrolled
Madhav Karunakar, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
287 Total Patients Enrolled