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

Allegheny Health Network (AHN)

Status and phase: Completed; Early Phase 1

Conditions: Vitamin D Deficiency

Treatments: Other: Placebo; Drug: Vitamin D2

Study type: Interventional

Funder types: Other

Identifiers

NCT04450199

2019-126

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

12 over encapsulated 50,000 IU Vitamin D2

Treatment:

Drug: Vitamin D2

Placebo

Placebo Comparator group

Description:

12 over encapsulated placebo tablets

Treatment:

Other: Placebo