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Vitamin Supplement

Vitamin D for Vitamin D Deficiency (VitD Trial)

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.

Eligible Conditions

Vitamin D Deficiency

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

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 • NCT01709110

12%

Back pain

Arthralgia

Fall

Humerus fracture

Hip fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

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

~3670

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