Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?

To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D2; Other: Placebo

Detailed Description

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
• Enrollment (Anticipated): 150
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Alan R Catanzariti, DPM, FACFAS; Phone Number: 412-688-7575; Email: alan.catanzariti@ahn.org
• Study Contact Backup: Name: Kimberly Lockridge; Phone Number: 412-688-7580; Email: Kimberly.lockridge2@ahn.org

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • The Foot & Ankle Institute/Western Pennsylvania Hospital
      • Contact: Alan R. Catanzariti, DPM, FACFAS; Phone Number: 412-688-7575; Email: alan.catanzariti@ahn.org
      • Contact: Angela Finamore; Phone Number: 412-359-8805; Email: Angela.Finamore@ahn.org
      • Sub-Investigator: Kimberly Lockridge, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis surgery
2. Vitamin D serum level <30 ng/mL including those concurrently taking vitamin D
3. Ambulatory
4. Women 18 years of age must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.

Exclusion Criteria:

1. Revision surgery
2. Tobacco use which has been shown to affect bone healing and increase risk of nonunion

3. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease (EXAMPLE below):

   AST/SGOT > 2.0 times the upper limit of normal ALT/SGPT > 2.0 times the upper limit of normal Total bilirubin > 2.0 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 100,000/mm3 Creatinine > 2.0 times the upper limit of normal

4. Preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
5. Preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
6. Open wounds to lower extremities which has been shown to increase risk of infection and nonunion
7. Any investigational drug use within 30 days prior to enrollment.
8. Participation in ongoing clinical research
9. Pregnant or lactating females.
10. Patients who are unable to swallow due to acuity of illness or physiologic reason
11. Patients who are unable to provide consent for the study including inability to read or speak English
12. Prisoners who are patients because of their vulnerable population and inability to follow-up
13. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D; 12 over encapsulated 50,000 IU Vitamin D2	Drug: Vitamin D2; Vitamin D tablets; Other Names: Vitamin D
Placebo Comparator: Placebo; 12 over encapsulated placebo tablets	Other: Placebo; Over encapsulated sugar pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Union	Arthrodesis Union using radiographic union determined by independent reviewers	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes SF-36 Questionnaire	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.	9 months
Patient Reported Outcomes VAS Survey Scores	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."	9 months

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: The Podiatry Foundation
• Investigators: Principal Investigator: Alan R Catanzariti, DPM, FACFAS, The Foot & Ankle Institute, West Penn Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 2019-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study has plans for publication and presentation to include a specialized peer reviewed international scientific journal and national conference, respectively. The Principal Investigator and Co-Investigator are part of the AHN and will have complete access to all data for the purpose of publication at study completion. Thanks to the generosity of funding from The Podiatry Foundation of Ohio, making this study possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes