An interventional study of Vitamin D3 in Vitamin D Deficiency Disease, sponsored by Madigan Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by Madigan Army Medical Center · 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 57th largest by enrollment, is one of 10 that started in 2016, is one of 113 with no phase, and was the 149th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:
Aziz Bhatti Shaheed Teaching Hospital · Sites in Pakistan
Ages 6–14
Bangladesh Medical University · Sites in Bangladesh
Ages 20–40 · Men only
National Taiwan University Hospital · Sites in Taiwan
Ages 18+
Peking University First Hospital · Sites in China
Ages 19+
Coordinación de Investigación en Salud, Mexico · Sites in Mexico
Ages 5–17
By country, each count listing its 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: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
228 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 17 · Phase 2 40 · Phase 3 38 · Phase 4 34
First in 2004; this study’s year is marked. 10 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 131 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 72 across the 228 interventional studies. Of the 179 that completed or were terminated, 44 (25%) have results posted.
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2 of 228 have an industry lead sponsor. The 10 most frequent:
Madigan Army Medical Center is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Madigan Army Medical Center has 3 studies 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 |
Add all 6 to your calendar (.ics) → With an account.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, from their registry updates:
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A genomics-based approach will target specific genes that may explain the response in biomarkers and symptoms before and after supplementation. One objective is to generate evidence-based recommendations for vitamin D supplementation in Soldiers who often experience musculoskeletal disorders and immune dysfunction impacting physical performance and military readiness. The investigation is designed to address these specific aims: 1) explore vitamin D status in 105 Service Members to determine common symptoms associated with deficiency; 2) examine the effect of vitamin D levels on gene expression from select genes known to influence metabolism, bone density, and immune function; and 3) evaluate changes in gene expression between groups receiving high or low supplementation, and compare to healthy controls. Follow-up at 15 months will evaluate circulating vitamin D.
A genomics-based approach will target identified candidate genes and search for variants that may explain the response observed in biomarkers and symptoms when deficient individuals are repleted. The long-term objective of this study is to translate findings from next-generation sequencing (NGS) technology into clinically meaningful data regarding vitamin D supplementation for Service Members (SM) who may be at risk for musculoskeletal disorders and immune dysfunction that impacts physical performance and military readiness. We propose the following specific aims: 1) explore the phenotypic expression of vitamin D status in a cohort of SM to determine common symptoms associated with deficiency/insufficiency states; 2) examine the effect of vitamin D levels on broad gene expression from carefully chosen candidate genes known to influence vitamin D status, bone density, and immune function; 3) evaluate changes in gene expression levels between and within groups supplemented with low vs high vitamin D, and compare to healthy controls, and 4) examine the relationship between vitamin D deficiency and the clinically relevant outcomes of stress fracture and high blood pressure before and after supplementation to a therapeutic plasma level of 25(OH)D. This prospective, randomized, double-blind trial will enroll 105 SM in the Northwest to evaluate frequency, symptoms, and genomic expression of vitamin D levels using survey instruments, immunologic and bone biomarkers, and NGS of white blood cells pre- and post-supplementation with oral vitamin D over 3 months. Participant follow-up at 12 months will evaluate maintenance of adequate circulating vitamin D; this timeframe represents a typical deployment period.
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:
Subjects in this arm have a normal serum level of 25(OH)D, \>30 ng/mL. Subjects submit to blood draws and biometric tests (DXA, body composition, BP) and questionnaires on 3 occasions. They do not receive vitamin D3 supplementation.
Dietary Supplement: Vitamin D3
Subjects in this group have been identified as having a level of 25(OH)D of \< 30 ng/mL and are randomized to receive vitamin D3 supplementation of 2000 IU daily for 3 months.
Dietary Supplement: Vitamin D3
Subjects in this group have been identified as having a level of 25(OH)D of \<30 ng/mL and are randomized to receive vitamin D3 supplementation of 5000 IU daily for 3 months.
Dietary Supplement: Vitamin D3
As in Arms
Also known as: Cholecalciferol
25(OH)D
Serum measure of 25(OH) at baseline, 3 months, and 15 months
Time frame: 15 months
Vitamin D gene expression
Gene expression analysis will be used to determine relationship between low and high dose vitamin D supplementation and 25(OH)D levels, blood pressure, bone density, and body fat
Time frame: 3 months
Plan to share: No
Ran from Jan 2016 to primary completion in Jun 2018, 29 months.
Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 29 months is above that.
Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Madigan Army Medical Center