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Clinical trial

Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis

ID
Name
Pro00095065
Description
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively. This study will assess the effect of vitamin D supplementation on patient outcomes following ankle arthrodesis or first metatarsophalangeal joint arthrodesis.
Trial arms
Trial start
2020-12-21
Estimated PCD
2024-09-01
Trial end
2024-11-01
Phase
Early phase I
Treatment
Vitamin D3
50,000 IU Vitamin D3 weekly for 8 weeks
Arms:
Vitamin D Supplementation Group
Size
90
Primary endpoint
Post-surgical complication rate following Vitamin D3 supplementation
6 months
Eligibility criteria
Inclusion Criteria: * Subject is ≥ 18 years of age * Subject is undergoing ankle arthrodesis or MTP arthrodesis * Subject speaks and understands English Exclusion Criteria: * Subject is \< 18 years of age * Subject has an active joint infection * Subject is unable to provide consent * Subject is a prisoner
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive either standard of care or supplemental Vitamin D3 following total ankle arthroplasty, ankle arthrodesis, or first metatarsophalangeal joint arthrodesis.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-02-01

1 organization

1 drug

2 indications

Organization
Prisma Health-Midlands
Drug
Vitamin D3
Indication
Ankle Fusion
Indication
MTP Arthrodesis