Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
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|ClinicalTrials.gov Identifier: NCT04450199|
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D2 Other: Placebo||Early Phase 1|
This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient (<30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.
The study will be conducted at 4 investigative sites within the Allegheny Health Network; West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics & Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects are entering the follow-up phase of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The specific aim of this study is to assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing rates. With this information the investigators hope to ascertain if vitamin D supplementation in the perioperative period leads to superior fusion rates than does no supplementation.|
|Masking Description:||The patients will be blinded for the duration of the study. This will be accomplished by providing the patients with over encapsulated vitamin D and placebo in pill bottles. Twelve (12) over encapsulated 50,000 IU vitamin D2 or placebo tablets will be packaged in pill bottles for patient use. The Foot & Ankle Institute CRC will document which drug the patients received.|
|Official Title:||Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Vitamin D
12 over encapsulated 50,000 IU Vitamin D2
Drug: Vitamin D2
Vitamin D tablets
Other Name: Vitamin D
Placebo Comparator: Placebo
12 over encapsulated placebo tablets
Over encapsulated sugar pills
- Time to Union [ Time Frame: 9 months ]Arthrodesis Union using radiographic union determined by independent reviewers
- Patient Reported Outcomes SF-36 Questionnaire [ Time Frame: 9 months ]Change in patient reported SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
- Patient Reported Outcomes VAS Survey Scores [ Time Frame: 9 months ]Change in patient reported VAS survey scores. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". ... The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450199
|Contact: Alan R Catanzariti, DPM, FACFASemail@example.com|
|Contact: Kimberly Lockridge||412-688-7580||Kimberly.firstname.lastname@example.org|
|United States, Pennsylvania|
|The Foot & Ankle Institute/Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Alan R Catanzariti, DPM, FACFAS||The Foot & Ankle Institute, West Penn Hospital|