Skip to main content
OpenTrials
Completed

NCT Number: NCT01691833

The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

About this study

Vitamin D plays an important role in maintaining calcium and phosphate balance in the body and is important for maintenance of bone formation, remodeling, and healing. An extensive literature search indicates that although there is evidence that vitamin D deficiency is associated with fracture risk, there is no evidence of the role of vitamin D deficiency in subsequent failure to heal. The aims of study were to: 1) quantify the rate of hypovitaminosis D in an orthopedic trauma population in the Southeastern United States; 2) determine the rate of nonunion in vitamin D deficient patients, and 3) assess the feasibility of acute high-dose vitamin-D supplementation in hypovitaminosis D patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presence of a long bone fracture (humerus, femur, or tibia)
  • age greater than or equal to 18 years
  • ability to follow-up at our clinic for 12 months

Exclusion criteria

  • pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor, cyst, or Paget's disease)
  • open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C (i.e. significant soft-tissue and bone devitalization)
  • presence of multiple fractures
  • delay in presentation for initial treatment of more than 2 weeks from the time of injury
  • 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)
  • pregnant patients
  • patients who are unable to provide consent for the study
  • patients who are unable to swallow due to acuity of illness or physiologic reason
  • prisoners who are patients because of their vulnerable population and inability to follow-up

Treatment and study plan

Vitamin D

Dietary Supplement

Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.

Placebo

Dietary Supplement

Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Primary outcomes

  1. Fracture Union

    Time frame: up to 9 months post-surgery

    Fracture Union is define as either clinical or radiological union. Clinical union defined as the absence of pain at the fracture site with the ability to bear full weight on the extremity without pain for activities of daily living (ambulation, lifting, carrying). Radiological union was determined by two blinded, independent review-ers and defined as the presence of bridging callus across at least three of four cortices or two of four cortices with a stable implant. When discrepancies between clinical and radiological union arose, the clinical assessment of union was preferred. Discrepancies in radiological outcomes were re-examined and a consensus view was obtained between reviewers if needed, to determine the outcome.If a patient did not meet the criteria for union and had at least nine months of follow•up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.

  2. Fracture Non-union

    Time frame: 9 months

    If a patient did not meet the criteria for union and had at least nine months of follow-up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.

Secondary outcomes

  1. Fixation Failure

    Time frame: three months

    Early failure of fixation was defined as the need to revise the fixation within three months.

  2. Deep Infection

    Time frame: 15 months

    A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia.

  3. Lost to Follow-up

    Time frame: 15 months

    Lost to follow-up if they did not meet the criteria for an outcome by 15 months after injury or surgery; were without another scheduled follow-up appointment, could not be contacted or refused to return for evaluation or send alternate records when contacted.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: VitD

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2012
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.