Trial Outcomes & Findings for The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates (NCT NCT01691833)

Last Updated: 2022-07-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

113 participants

Primary outcome timeframe

up to 9 months post-surgery

Results posted on

2022-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	Normovitaminosis Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Overall Study STARTED	50	50	13
Overall Study COMPLETED	49	49	13
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D n=50 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.	Placebo n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.	Total n=113 Participants Total of all reporting groups
Age, Customized	38.9 years STANDARD_DEVIATION 13.1 • n=5 Participants	35.5 years STANDARD_DEVIATION 12.1 • n=7 Participants	39.9 years STANDARD_DEVIATION 11.7 • n=5 Participants	37.4 years STANDARD_DEVIATION 12.6 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	38 Participants n=7 Participants	8 Participants n=5 Participants	80 Participants n=4 Participants
Injury Type Humerus	8 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Injury Type Femur	25 Participants n=5 Participants	25 Participants n=7 Participants	5 Participants n=5 Participants	55 Participants n=4 Participants
Injury Type Tibia	17 Participants n=5 Participants	18 Participants n=7 Participants	5 Participants n=5 Participants	40 Participants n=4 Participants
Tobacco use ( current)	24 Participants n=5 Participants	23 Participants n=7 Participants	8 Participants n=5 Participants	55 Participants n=4 Participants
BMI	29.4 kg/m2 STANDARD_DEVIATION 6.3 • n=5 Participants	27.8 kg/m2 STANDARD_DEVIATION 6.5 • n=7 Participants	25.5 kg/m2 STANDARD_DEVIATION 4.87 • n=5 Participants	28.3 kg/m2 STANDARD_DEVIATION 6.5 • n=4 Participants
Operatively treated	41 Participants n=5 Participants	42 Participants n=7 Participants	11 Participants n=5 Participants	94 Participants n=4 Participants
Prior use of Vitamins	29 Participants n=5 Participants	36 Participants n=7 Participants	6 Participants n=5 Participants	71 Participants n=4 Participants
Diabetes mellitus	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 9 months post-surgery

Outcome measures

Outcome measures
Measure	Hypovitaminosis- Vitamin D Group n=50 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.	Hypovitaminosis- Placebo Group n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Fracture Union	40 Participants	39 Participants	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypovitaminosis- Vitamin D Group n=50 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.	Hypovitaminosis- Placebo Group n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Fracture Non-union	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: three months

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

Outcome measures

Outcome measures
Measure	Hypovitaminosis- Vitamin D Group n=50 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.	Hypovitaminosis- Placebo Group n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Fixation Failure	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 15 months

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

Outcome measures

Outcome measures
Measure	Hypovitaminosis- Vitamin D Group n=50 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.	Hypovitaminosis- Placebo Group n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Deep Infection	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypovitaminosis- Vitamin D Group n=50 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.	Hypovitaminosis- Placebo Group n=50 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. Placebo: Patients that are Vitamin D deficient maybe randomized to the placebo group D.	Normovitaminosis n=13 Participants Patients with normovitaminosis D (levels greater than or equal to 30ng/ml) did not participate in the randomized portion of the study.
Lost to Follow-up	7 Participants	7 Participants	0 Participants

Adverse Events

Hypovitaminosis- Vitamin D Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypovitaminosis- Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normovitaminosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Seymour

Carolinas Healthcare System

Phone: 704-355-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place