High Vitamin D3 Supplementation for Vitamin D Deficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vitamin D Deficiency+3 More
Vitamin D3 - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether giving Vitamin D before surgery can reduce postoperative complications.

Eligible Conditions
  • Vitamin D Deficiency
  • Hip structure
  • Arthropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Preoperative visit to three months post-op

Day of surgery to to three months post-op
Vitamin D status
Preoperative visit to three months post-op
Hip disability and Osteoarthritis Outcome Score (HOOS)
Pain Levels: visual analog scale (VAS)
Patient-Reported Outcomes Measurement Information System (PROMIS)
Readmission, reoperation, wound complications, and PJI

Trial Safety

Trial Design

3 Treatment Groups

High Vitamin D3 Supplementation
1 of 3
No supplementation
1 of 3
Low Vitamin D3 Supplementation
1 of 3

Active Control

900 Total Participants · 3 Treatment Groups

Primary Treatment: High Vitamin D3 Supplementation · No Placebo Group · N/A

High Vitamin D3 Supplementation
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement
No supplementationNoIntervention Group · 1 Intervention: No supplementation · Intervention Types:
Low Vitamin D3 Supplementation
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative visit to three months post-op

Who is running the clinical trial?

Newton-Wellesley HospitalOTHER
12 Previous Clinical Trials
3,727 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,470 Previous Clinical Trials
9,706,733 Total Patients Enrolled
4 Trials studying Vitamin D Deficiency
983 Patients Enrolled for Vitamin D Deficiency
Massachusetts General HospitalOTHER
2,675 Previous Clinical Trials
30,827,884 Total Patients Enrolled
10 Trials studying Vitamin D Deficiency
2,305 Patients Enrolled for Vitamin D Deficiency
Antonia F Chen, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
177 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a pre-operative serum 25(OH)D level of 10 ng/mL or higher.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References