Trial | NCT04450199  Report issue

Official Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    150
To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).
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 Started
Jul 24
2020
Primary Completion
Mar 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Aug 01
2022

Drug Vitamin D2

Vitamin D tablets

  • Other names: Vitamin D

Other Placebo

Over encapsulated sugar pills

Vitamin D Active Comparator

12 over encapsulated 50,000 IU Vitamin D2

Placebo Placebo Comparator

12 over encapsulated placebo tablets

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.
No Results Posted