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

Primary Purpose

Vitamin D Deficiency

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2
Placebo
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Foot & Ankle Institute/Western Pennsylvania HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

12 over encapsulated 50,000 IU Vitamin D2

12 over encapsulated placebo tablets

Outcomes

Primary Outcome Measures

Time to Union
Arthrodesis Union using radiographic union determined by independent reviewers

Secondary Outcome Measures

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.
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."

Full Information

First Posted
June 11, 2020
Last Updated
July 29, 2022
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
The Podiatry Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04450199
Brief Title
Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Official Title
Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
The Podiatry Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
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.
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
12 over encapsulated 50,000 IU Vitamin D2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 over encapsulated placebo tablets
Intervention Type
Drug
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Over encapsulated sugar pills
Primary Outcome Measure Information:
Title
Time to Union
Description
Arthrodesis Union using radiographic union determined by independent reviewers
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes SF-36 Questionnaire
Description
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.
Time Frame
9 months
Title
Patient Reported Outcomes VAS Survey Scores
Description
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."
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis surgery Vitamin D serum level <30 ng/mL including those concurrently taking vitamin D Ambulatory 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: Revision surgery Tobacco use which has been shown to affect bone healing and increase risk of nonunion 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 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) 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) Open wounds to lower extremities which has been shown to increase risk of infection and nonunion Any investigational drug use within 30 days prior to enrollment. Participation in ongoing clinical research Pregnant or lactating females. Patients who are unable to swallow due to acuity of illness or physiologic reason Patients who are unable to provide consent for the study including inability to read or speak English Prisoners who are patients because of their vulnerable population and inability to follow-up Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan R Catanzariti, DPM, FACFAS
Phone
412-688-7575
Email
alan.catanzariti@ahn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Lockridge
Phone
412-688-7580
Email
Kimberly.lockridge2@ahn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan R Catanzariti, DPM, FACFAS
Organizational Affiliation
The Foot & Ankle Institute, West Penn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Foot & Ankle Institute/Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan R. Catanzariti, DPM, FACFAS
Phone
412-688-7575
Email
alan.catanzariti@ahn.org
First Name & Middle Initial & Last Name & Degree
Angela Finamore
Phone
412-359-8805
Email
Angela.Finamore@ahn.org
First Name & Middle Initial & Last Name & Degree
Kimberly Lockridge, DPM

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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

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