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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. |
|
| Placebo | Placebo Comparator | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. |
|
| Normovitaminosis | No Intervention | Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fracture Union | 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. | up to 9 months post-surgery |
| Fracture Non-union | 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fixation Failure | Early failure of fixation was defined as the need to revise the fixation within three months. | three months |
| Deep Infection | A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhav Karunakar, MD | Wake Forest University Health Sciences | Principal Investigator |
| Rachel Seymour, PhD | Wake Forest University Health Sciences | Study Director |
| Christine Churchill, MA | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypovitaminosis- Vitamin D Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D. |
| FG001 | Hypovitaminosis- Placebo Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D. |
| FG002 | Normovitaminosis | Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fracture Union | 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. | Posted | Count of Participants | Participants | up to 9 months post-surgery |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypovitaminosis- Vitamin D Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Seymour | Carolinas Healthcare System | 704-355-2000 | Rachel.Seymour@carolinas.org |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Dietary Supplement | Patients that are Vitamin D deficient maybe randomized to the placebo group D. |
|
| 15 months |
| Lost to Follow-up | 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. | 15 months |
| Placebo |
Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D. |
| BG002 | Normovitaminosis | Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Injury Type | Count of Participants | Participants |
|
| Tobacco use ( current) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Operatively treated | Count of Participants | Participants |
|
| Prior use of Vitamins | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Vitamin D: Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D. |
| OG001 | Hypovitaminosis- Placebo Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D. |
| OG002 | Normovitaminosis | Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study. |
|
|
| Primary | Fracture Non-union | 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. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Fixation Failure | Early failure of fixation was defined as the need to revise the fixation within three months. | Posted | Count of Participants | Participants | three months |
|
|
|
| Secondary | Deep Infection | A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Lost to Follow-up | 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. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Hypovitaminosis- Placebo Group | Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Normovitaminosis | Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009750 |
| Nutritional and Metabolic Diseases |