CompletedPhase 2

Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing

United States, Canada102 participantsStarted 2016-11-21

Plain-language summary

The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.

Age range18 Years – 50 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.

✓. Adult men or women ages 18-50 years
✓. Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture
✓. Fracture treated with a reamed, locked, intramedullary nail
✓. Acute fracture (enrolled within 7 days of injury)
✓. Provision of informed consent.

✕. Osteoporosis
✕. Stress fractures
✕. Elevated serum calcium (\>10.5 mg/dL)
✕. Atypical femur fractures as defined by American Society for Bone and Mineral Research (ASBMR) criteria
✕. Pathological fractures secondary to neoplasm or other bone lesion
✕. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.
✕. Patients with hyperhomocysteinemia
✕. Patients with an allergy to vitamin D or another contraindication to being prescribed vitamin D

Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP)

Timeframe: 3 months post-injury

NCT IDNCT02786498

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08

Results submitted2020-12-03

Who can participate

Age range18 Years – 50 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.

✓. Adult men or women ages 18-50 years
✓. Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture
✓. Fracture treated with a reamed, locked, intramedullary nail
✓. Acute fracture (enrolled within 7 days of injury)
✓. Provision of informed consent.

✕. Osteoporosis
✕. Stress fractures
✕. Elevated serum calcium (\>10.5 mg/dL)
✕. Atypical femur fractures as defined by American Society for Bone and Mineral Research (ASBMR) criteria
✕. Pathological fractures secondary to neoplasm or other bone lesion
✕. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.
✕. Patients with hyperhomocysteinemia
✕. Patients with an allergy to vitamin D or another contraindication to being prescribed vitamin D

What they're measuring

Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX)

Timeframe: 3 months post-injury

Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP)

Timeframe: 3 months post-injury