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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450199
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : July 9, 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)

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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D2 Other: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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
Other: Placebo
Over encapsulated sugar pills




Primary Outcome Measures :
  1. Time to Union [ Time Frame: 9 months ]
    Arthrodesis Union using radiographic union determined by independent reviewers


Secondary Outcome Measures :
  1. 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.

  2. 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."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Alan R Catanzariti, DPM, FACFAS 412-688-7575 alan.catanzariti@ahn.org
Contact: Kimberly Lockridge 412-688-7580 Kimberly.lockridge2@ahn.org

Locations
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United States, Pennsylvania
The Foot & Ankle Institute/Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
The Podiatry Foundation
Investigators
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Principal Investigator: Alan R Catanzariti, DPM, FACFAS The Foot & Ankle Institute, West Penn Hospital
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Responsible Party: Alan Catanzariti, Program Director, Foot and Ankle Residency Training Program, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT04450199    
Other Study ID Numbers: 2019-126
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents