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

NCT ID: NCT04450199

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-24
• Study Completion Date: 2024-03-11

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 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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vitamin D

12 over encapsulated 50,000 IU Vitamin D2

Group Type: ACTIVE_COMPARATOR

Vitamin D2

Intervention Type: DRUG

Vitamin D tablets

Placebo

12 over encapsulated placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Over encapsulated sugar pills

Interventions

Vitamin D2

Vitamin D tablets

Intervention Type: DRUG

Placebo

Over encapsulated sugar pills

Intervention Type: OTHER

Other Intervention Names

Vitamin D

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Podiatry Foundation

UNKNOWN

Sponsor Role: collaborator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: lead

Responsible Party

Alan Catanzariti

Program Director, Foot and Ankle Residency Training Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan R Catanzariti, DPM, FACFAS

Role: PRINCIPAL_INVESTIGATOR

The Foot & Ankle Institute, West Penn Hospital

Locations

The Foot & Ankle Institute/Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

2019-126

Identifier Type: -

Identifier Source: org_study_id