An interventional study of Cholecalciferol (Vitamin D3) in Vitamin D Deficiency, Stress Fracture and Athletic Injuries, sponsored by Prisma Health-Midlands. Completed. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Prisma Health-Midlands · Not applicable, Interventional, and Treatment
Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 72nd largest by enrollment, is one of 20 that started in 2015, is one of 113 with no phase, and was the 160th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's enrollment of 118 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Each count lists the studies.
Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and 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: all sexes · healthy volunteers too.
The full table on the hub →228 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 20 started in 2015.
Median enrollment 72 across the 228 interventional studies. Of the 179 that completed or were terminated, 44 (25%) have results posted.
2 of 228 have an industry lead sponsor. The 10 most frequent:
Prisma Health-Midlands is the lead sponsor of 11 studies on the registry; none are open to participants now.
Prisma Health-Midlands has 1 study filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
6 of the studies testing cholecalciferol in Vitamin D Deficiency that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03188796Phase 3Medical University of GrazThe VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients | 2027-07 |
| NCT04677816Wake Forest University Health SciencesImpact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients | 2026-12 |
| NCT03613116University of California, DavisHigh-dose Vitamin D Supplements in Older Adults | 2026-12-31 |
| NCT07914478Aziz Bhatti Shaheed Teaching HospitalRole of Vitamin D Supplementation in Children With Irritable Bowel Syndrome | 2027-03-30 |
| NCT07006714University of MiamiPreoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) | 2027-07-01 |
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, from their registry updates:
The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. It is hypothesized that providing supplemental treatment to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of stress fractures. By recording the dates and specific occurrences of fractures, it may be possible to correlate injury rates with seasons, providing more supportive data to pre-existing literature.
This area of research is lacking in the quantity of prospective studies. Previous studies primarily focus on adolescent, elder, or military recruit populations. While literature has shown that vitamin D plays an important role in bone health, there are no previous studies that directly examine vitamin D deficiency and supplemental treatment in conditioned collegiate athlete populations. This study will add to the existing knowledge and will provide a more specific analysis for athletes.
This study will focus on athletes who are at a higher risk of lower extremity stress fractures. Specifically, this study will be looking at male and female athletes on the track, cross-country, soccer, and basketball teams at the University of South Carolina. During the pre-season physical of each student athlete, serum vitamin D levels will be taken and recorded. There will be a certified nurse to draw the blood samples. This will take place at the University of South Carolina Athletic Department and/or the Palmetto Health Lab at 2 Medical Park. Potentially, every athlete of the given teams will be enrolled in the study unless they choose not to. Only subjects showing concentrations below 30 ng/mL, which is indicative of insufficient or deficient levels, will be provided supplemental treatment of 25-(OH) vitamin D. Every enrolled subject will be monitored for injury throughout the season. Any and all injuries will be positively identified, and any confirmed stress fractures will be recorded. Data from prospective seasons will be compared to an incidence percentage of athletes from previous seasons. Previous athletes did not receive any vitamin D treatment. These will be used as a control to determine if treatment affected the occurrence of stress fractures. All physicals and tests will be performed at the University of South Carolina Sports Medicine clinic by the sports medicine staff.
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:
Athletes with Vitamin D levels lower than 30ng/mL will be treated with the supplement for eight weeks.
Dietary Supplement: Cholecalciferol (Vitamin D3)
Athletes with Vitamin D levels higher than 30ng/mL were enrolled and compared but not treated.
Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood.
Incidence and prevalence of stress fractures in athlete cohorts
To compare the incidence and prevalence of student athletes experiencing stress fractures during the 2015-16 academic year with the five previous years of reported data.
Time frame: 5 Years
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Prisma Health-Midlands