An interventional study of Vitamin D3 (cholecalciferol) in Diabetes Complications, Vitamin D Deficiency and Vitamin D Supplementation, sponsored by University of Avignon. Completed at 1 site in France. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Avignon · Not applicable, Interventional, and Supportive care
Among 11 studies in Diabetes Complications with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Diabetes Complications · France.
Among the 11 studies in Diabetes Complications with a site in France, this one is the only one that started in 2018, is one of 6 with no phase, and was the 5th registered.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
Browse Diabetes Complications studies →3 of the 11 studies in Diabetes Complications with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire de Nīmes · Sites in France
University Hospital, Toulouse · Sites in France
Ages 18+
Centre Hospitalier Universitaire de Nīmes · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 45 Diabetes Complications studies recruiting now, 27 (60%) set no upper age limit and 12 (27%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 40 Years to 65 Years · 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.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Median enrollment 125 across the 7 interventional studies, 116 across the 4 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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2 of 11 have an industry lead sponsor. The 8 most frequent:
University of Avignon is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
University of Avignon has 2 studies filed under Diabetes Complications — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetes Complications with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05491577Centre Hospitalier Universitaire de NīmesFactors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot | 2027-07-22 |
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Among the 11 studies in Diabetes Complications with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Vitamin D deficiency is recognized as a cardiovascular risk factor. Diabetic patients are of major risk for cardiovascular diseases and typically present with Vitamin D deficiencies. Myocardial function is altered in both type I and II diabetic patients but no data is today available on the effect of Vitamin D supplementation.
The aim of the study will be to investigate myocardial function (by deformation imaging techniques) at rest and during low-dose dobutamine stress echocardiography in both type I and II diabetic patients. Within each diabetic population, myocardial function will be compared at baseline between the vitamin D deficient and non-deficient individuals. Furthermore, the investigators will study the effect of a 3 month supplementation in those with deficiencies.
Rationale:
Vitamin D exerts a principal role in homeostasis of calcium and phosphorus. However, recent studies indicated also its important function in cell differentiation, proliferation and growth as well as regulation of the immune system.
Vitamin Deficiency is today recognized as a risk factor for cardiovascular disease (CVD). Diabetic patients are of major risk for CVD. They typically present with Vitamin D deficiencies. Experimental studies have established as a result of Vitamin D deficiency alterations in intrinsic cardiac contractile and relaxation properties, hypertrophy and fibrosis. Regional myocardial function is altered in both type I and II diabetic patients. In type II diabetic individuals, myocardial dysfunction is furthermore exacerbated in those with Vitamin D deficiency compared to those with normal levels. In patients free from CV risk and deficient in Vitamin D, regional myocardial function improved after Vitamin D supplementation. To the best of our knowledge, no scientific study is today available on the effect of Vitamin D supplementation on regional myocardial function in diabetic patients deficient in vitamin D.
Objectives and Methodology:
All the diabetic patients will benefit from a clinical (medical history, drug therapy, ECG, blood pressure, ...), anthropometric (abdominal obesity indices) and biological (carbohydrate and lipid balance, markers of inflammation and heart failure, vitamin D glucose and insulin status) evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic function) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the assessment of regional myocardial longitudinal deformations as well as in the parasternal short axis (base, mid and apex) for the evaluation of circumferential deformations and basal and apical rotation and torsion, at rest and under low dose dobutamine (110 and 120 bpm).
Vitamin D supplementation:
Patients with vitamin D deficiency will be investigated before and after a 3 month cholecalciferol supplementation.
For this purpose 25-OH-D3 with be evaluated at baseline.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.
Dietary Supplement: Vitamin D3 (cholecalciferol)
3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.
Dietary Supplement: Vitamin D3 (cholecalciferol)
* Patients with 29≤ 25-OH-D3 ≥20 ng/mL will receive 200 000 UI orally the first month (100 000 UI at T0 + 100 000 UI at T0+15 days, UVEDOSE™ Laboratoires Crinex, Montrouge, France) followed for the last 2 months by one daily dose (5 drops orally = 1 000 UI/day, DÉDROGYL™ , DB Pharma, La Varenne-Saint-Hilaire, France). * Patients with : 19≤ 25-OH-D3 ≥10 ng/mL will receive orally 300 000 UI (100 000 UI at T0 + 100 000 UI at T0+23days + 100 000 UI at T0+45days; UVEDOSE™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™ ). * Patients with : 25-OH-D3 \<10 ng/mL will receive orally 400 000 UI (100 000 UI at T0 + 100 000 UI at T0+15days + 100 000 UI at T0+30 days + 100 000 UI at T0+45days, UVEDOSE™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™).
Change in longitudinal strain
Index of myocardial function measured using deformation imaging technique by echocardiography, at rest and under dobutamine stress.
Time frame: Before and after 3 month of Vitamin D supplementation
Ran from Feb 2018 to primary completion in Sep 2023, 66 months.
Of 62 non-industry interventional studies with no phase under Diabetes Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 66 months is above that.
Counting every sponsor, half of 69 studies reached it within 28 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
University of Avignon