A Phase 4 interventional study of Didrogyl in Hypovitaminosis D and Cardiovascular Diseases, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Phase 4, Interventional, and Treatment
Among 12 studies testing calcifediol in Vitamin D Deficiency — 1 open to participants now, 1 under way, none of them phase 3. Calcifediol · Vitamin D Deficiency.
Among the 12 studies testing calcifediol in Vitamin D Deficiency, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 3 in phase 4, and was the 8th registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →1 of the 12 studies testing calcifediol in Vitamin D Deficiency is open now. Recruiting first, the newest first:
Parc de Salut Mar
Ages 18–75
Calcifediol: first FDA approval 1980 (CALDEROL). 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: 55 Years to 85 Years · 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.
12 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 1 · Phase 2 2 · Phase 3 5 · Phase 4 3
First in 2012; this study’s year is marked. 1 started in 2017.
This study's enrollment of 74 is close to the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 76 across the 12 interventional studies. Of the 10 that completed or were terminated, 5 (50%) have results posted.
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6 of 12 have an industry lead sponsor. The 9 most frequent:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio has 1 study filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
1 of the studies testing calcifediol in Vitamin D Deficiency that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06258850Parc de Salut MarREstoration of VItamin D in Pulmonary Arterial Hypertension | 2027-06 |
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Among the 12 studies testing calcifediol in Vitamin D Deficiency, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.
Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Didrogyl 10 ml: 10 drops a day to obtain levels of vitamin D \> 30 ng /ml. Once these values are obtained lower the dose to 4-5 drops a day, with the aim, however, of keeping the plasma values between 30 and 60 ng/ml during 6 months of the study
Drug: Didrogyl
Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels\> 30 ng / ml are obtained. Once these values have been obtained, the dosage can be reduced to a dosage of 4/5 drops of calcifediol (1 drop contains 5mcg of calcifediol) with the aim to maintain the plasma values of 25 (OH) D in a optimal range between 30-60 ng / ml during the 6 month of the duration of the study.
Evaluation of improvement of ejection fraction (FE)
Evaluation of improvement of ejection fraction (FE) or longitudinal strain calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency who underwent supplementation with calcifediol, during functional recovery after major orthopedic surgery
Time frame: 6 months
Ran from Jan 2017 to primary completion in Sep 2017, 8 months.
Of 36 non-industry phase 4 interventional studies under Vitamin D Deficiency, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 8 months is below that.
Counting every sponsor, half of 37 studies reached it within 18 months; a quarter within 8 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 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcifediol
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio →