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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 : Recruiting
First Posted : June 29, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
The Podiatry Foundation
Information provided by (Responsible Party):
Alan Catanzariti, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Tracking Information
First Submitted Date  ICMJE June 11, 2020
First Posted Date  ICMJE June 29, 2020
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE July 24, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
Time to Union [ Time Frame: 9 months ]
Arthrodesis Union using radiographic union determined by independent reviewers
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • 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."
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Official Title  ICMJE Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
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: Single (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.
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Drug: Vitamin D2
    Vitamin D tablets
    Other Name: Vitamin D
  • Other: Placebo
    Over encapsulated sugar pills
Study Arms  ICMJE
  • Active Comparator: Vitamin D
    12 over encapsulated 50,000 IU Vitamin D2
    Intervention: Drug: Vitamin D2
  • Placebo Comparator: Placebo
    12 over encapsulated placebo tablets
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alan R Catanzariti, DPM, FACFAS 412-688-7575 alan.catanzariti@ahn.org
Contact: Kimberly Lockridge 412-688-7580 Kimberly.lockridge2@ahn.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04450199
Other Study ID Numbers  ICMJE 2019-126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Alan Catanzariti, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study Sponsor  ICMJE Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators  ICMJE The Podiatry Foundation
Investigators  ICMJE
Principal Investigator: Alan R Catanzariti, DPM, FACFAS The Foot & Ankle Institute, West Penn Hospital
PRS Account Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP