An interventional study of cholecalciferol (Euro-Pharm International, Canada) and Placebo in Deficiency, Vitamin D and Insulin Resistance, sponsored by Université d'Auvergne. Completed. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Université d'Auvergne · Not applicable, Interventional, and Prevention
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 76th largest by enrollment, is one of 20 that started in 2015, is one of 113 with no phase, and was the 165th 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: 65 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. 20 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 115 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:
Université d'Auvergne is the lead sponsor of 3 studies on the registry; none are open to participants now.
Université d'Auvergne has 2 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:
This tab as a report to print or save as PDF → With an account.
Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.
A low serum 25-hydroxyvitamin D [(25(OH) D)] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.
Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.
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.
-Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus
Exclusion Criteria:
patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.
The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)
Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)
The placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving.
Other: Placebo
Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
HOMA-IR
The HOMA-IR formula was as following: HOMA-IR = \[insulin (mU/L) × glucose (mg/dL)\]/22.5 where IR is the mutual of percentage sensitivity with a normal value of 1.0.
Time frame: 6 months
25 (OH)D
Vitamin D
Time frame: 6 months
BMI
Body mass Index
Time frame: 6 months
FBG
Fasting blood glucose
Time frame: 6 months
FBI
Fasting Blood inslin
Time frame: 6 months
HbA1C
Glycated hemoglobin
Time frame: 6 months
Total cholesterol
Total cholesterol
Time frame: 6 months
LDL cholesterol
LDL cholesterol
Time frame: 6 months
HDL cholesterol
HDL cholesterol
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
Ran from Jul 2015 to primary completion in Sep 2015, 2 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 2 months is below 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 Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Université d'Auvergne