Status:
COMPLETED
Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
The Podiatry Foundation
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-89 years
Phase:
EARLY_PHASE1
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 arthrode...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04450199
Start Date
July 24 2020
End Date
March 11 2024
Last Update
June 18 2024
Active Locations (1)
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1
The Foot & Ankle Institute/Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224