An interventional study of Vitamin D and Placebo in Hypovitaminosis D, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
Among 154 studies testing Vitamin D in Vitamin D Deficiency — 15 open to participants now, 16 under way, none of them phase 3. Vitamin D · Vitamin D Deficiency.
Among the 154 studies testing Vitamin D in Vitamin D Deficiency, this one is the 43rd largest by enrollment of the 153 interventional ones that give a count, is one of 8 that started in 2011, is one of 87 with no phase, and was the 46th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →15 of the 154 studies testing Vitamin D in Vitamin D Deficiency are open now, in 8 countries. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 13–21 · Women only
Future University in Egypt · Sites in Egypt
Ages 20–60 · Healthy volunteers
The Jerzy Kukuczka Academy of Physical Education in Katowice · Sites in Poland
Ages 17–60 · Healthy volunteers
Bangladesh Medical University · Sites in Bangladesh
Ages 51–70 · Men only
Bangladesh Medical University · Sites in Bangladesh
Ages 20–40 · Men only
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 16 · Phase 3 8 · Phase 4 27
First in 2001; this study’s year is marked. 8 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 113 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 75 across the 153 interventional studies. Of the 113 that completed or were terminated, 17 (15%) have results posted.
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2 of 154 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Wake Forest University Health Sciences has 5 studies filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 154 studies testing Vitamin D in Vitamin D Deficiency, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: 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.
Dietary Supplement: Placebo
Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.
Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.
Patients that are Vitamin D deficient maybe randomized to the placebo group D.
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.
Time frame: 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.
Time frame: 9 months
Fixation Failure
Early failure of fixation was defined as the need to revise the fixation within three months.
Time frame: 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.
Time frame: 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.
Time frame: 15 months
| Milestone | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Started | 50 | 50 | 13 |
| Completed | 49 | 49 | 13 |
| Not completed | 1 | 1 | 0 |
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.
| Participants | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Fracture Union | 40 | 39 | 10 |
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.
| Participants | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Fracture Non-union | 2 | 2 | 3 |
Early failure of fixation was defined as the need to revise the fixation within three months.
| Participants | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Fixation Failure | 1 | 1 | 0 |
A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia.
| Participants | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Deep Infection | 0 | 1 | 0 |
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.
| Participants | Hypovitaminosis- Vitamin D Group | Hypovitaminosis- Placebo Group | Normovitaminosis |
|---|---|---|---|
| Lost to Follow-up | 7 | 7 | 0 |
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypovitaminosis- Vitamin D Group | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Hypovitaminosis- Placebo Group | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Normovitaminosis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Customized(years) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Mean | 38.9 ± 13.1 | 35.5 ± 12.1 | 39.9 ± 11.7 | 37.4 ± 12.6 |
| Sex: Female, Male(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Female | 16 | 12 | 5 | 33 |
| Male | 34 | 38 | 8 | 80 |
| Injury Type(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Humerus | 8 | 7 | 3 | 18 |
| Femur | 25 | 25 | 5 | 55 |
| Tibia | 17 | 18 | 5 | 40 |
| Tobacco use ( current)(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Count of participants | 24 | 23 | 8 | 55 |
| BMI(kg/m2) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Mean | 29.4 ± 6.3 | 27.8 ± 6.5 | 25.5 ± 4.87 | 28.3 ± 6.5 |
| Operatively treated(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Count of participants | 41 | 42 | 11 | 94 |
| Prior use of Vitamins(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Count of participants | 29 | 36 | 6 | 71 |
| Diabetes mellitus(Participants) | Vitamin D | Placebo | Normovitaminosis | Total |
|---|---|---|---|---|
| Count of participants | 0 | 4 | 0 | 4 |
The record gives a start of Feb 2011, a primary completion of Jan 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2019, 2 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
Wake Forest University Health Sciences →