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

NCT04450199 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 2019-126
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Time to Union

  Arthrodesis Union using radiographic union determined by independent reviewers

  9 months

Secondary Outcomes (2)

• Patient Reported Outcomes SF-36 Questionnaire

  9 months

• Patient Reported Outcomes VAS Survey Scores

  9 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

12 over encapsulated 50,000 IU Vitamin D2

Drug: Vitamin D2

Placebo

PLACEBO COMPARATOR

12 over encapsulated placebo tablets

Other: Placebo

Interventions

Vitamin D2 DRUG

Vitamin D tablets

Also known as: Vitamin D

Vitamin D

Placebo OTHER

Over encapsulated sugar pills

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• The Podiatry Foundation: collaborator

Study Sites (1)

The Foot & Ankle Institute/Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Alan R Catanzariti, DPM, FACFAS

  The Foot & Ankle Institute, West Penn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Foot and Ankle Residency Training Program

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 29, 2020
• Study Start: July 24, 2020
• Primary Completion: December 1, 2023
• Study Completion: March 11, 2024
• Last Updated: June 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)