CompletedEarly Phase 1

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

United States25 participantsStarted 2020-07-24

Plain-language summary

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

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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):
✕. 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

Time to Union

Timeframe: 9 months

NCT IDNCT04450199

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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):
✕. 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