Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate? (ViDco)

Hospital del Trabajador de Santiago

Status: Unknown

Conditions: Fracture Healing; Tibial Fractures; Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3.; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03232216

ViDco

Details and patient eligibility

About

This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3 supplementation while the other will receive placebo.

Enrollment: 682 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Tibial fracture
• ASA physical status classification system I-II.
• 25 hydroxyvitamin D below 30ng/ml)
• Fracture treatment with reamed intramedullary nail

Exclusion criteria

• Open Fractures Gustillo III B and III C
• Closed Soft tissue injury with Tscherne classification of III
• Acute Compartment Syndrome
• Pathology fractures (That occur in abnormal bone, for example in the presence of tumor, cyst or Paget disease)
• Other Fractures in lower limbs or spine that does not allow full weight bearing of the operated tibia after 4 weeks
• More than 7 days of evolution from fracture occurrence
• Diabetes mellitus with HbA1c more or equal than 7%
• Peripheral vascular disease
• Rickets
• Pre-existing disorders of the metabolism of Vitamin D and/or homeostasis of calcium and phosphorous (ie. Hepatic insufficiency, congenital defects of the vitamin D metabolism, disorders of the parathyroid glands, hypo or hyper calcemia)
• Renal failure with glomerular filtration rate below 60ml/min according to MDRD-4.
• Patients using nephrotoxic medications in high doses, requiring periodical monitoring of glomerular filtration rate
• Patients undergoing with nephrotic syndrome or that suffered it in the past
• Patients that suffered nephrolithiasis or urolithiasis
• Pregnant women
• Patients with allergy to vitamin D or other contraindications for vitamin D3 prescription
• Patients that are taking multivitamin supplements containing vitamin D and will not suspend taking them during the study.
• Patients that are not able to swallow a cup of water

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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682 participants in 4 patient groups, including a placebo group

Vitamin D3 supplementation. Deficiency.

Experimental group

Description:

Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.

Treatment:

Dietary Supplement: Vitamin D3.

Placebo. Deficiency.

Placebo Comparator group

Description:

Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.

Treatment:

Dietary Supplement: Placebo

Vitamin D3 supplementation.Insufficiency

Experimental group

Description:

Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.

Treatment:

Dietary Supplement: Vitamin D3.

Placebo. Insufficiency.

Placebo Comparator group

Description:

Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.

Treatment:

Dietary Supplement: Placebo