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Myocardial Function and Vitamin D Supplementation in Diabetes. (VitaDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437421
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Avignon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Complications Vitamin D Deficiency Vitamin D Supplementation Myocardial Dysfunction Dietary Supplement: Vitamin D3 (cholecalciferol) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Type I and II diabetic patients will be investigated. Within each diabetic population, vitamin D deficient and non-deficient individuals will be compared at baseline. Then, within each diabetic population, those with vitamin D deficiency at baseline will be compared before and after a 3 month vitamin D supplementation.
Masking: Single (Outcomes Assessor)
Masking Description: Single-masked study. Clinicians and researchers in charge of main outcomes (eg cardiac remodelling and global function, regional myocardial function) measurements will not be aware of group allocation (eg vitamin D deficient and non-deficient sub-groups) and time study (eg baseline or post vitamin D supplementation).
Primary Purpose: Supportive Care
Official Title: Effect of Vitamin D Supplementation on Myocardial Regional Function by Dobutamine Stress Echocardiography in Diabetic Patients.
Actual Study Start Date : February 4, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Type II diabetic patients
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™).

Experimental: Type I diabetic patients
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™).




Primary Outcome Measures :
  1. Change in longitudinal strain [ Time Frame: Before and after 3 month of Vitamin D supplementation ]
    Index of myocardial function measured using deformation imaging technique by echocardiography, at rest and under dobutamine stress.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Male and female 40-65 years old, asymptomatic and free from epicardial coronary artery disease.

Exclusion Criteria:

  • body mass index > 35 kg / m2, defining severe obesity,
  • Under insulin therapy (for Type II only)
  • Poorly controlled hypertension (> 140/95)
  • LV ejection fraction (LVEF) < 55%
  • Peripheral vascular disease (> stage II of Leriche)
  • Heart disease or known coronary artery disease,
  • Known and poorly compensated thyroid dysfunction,
  • Nocturnal apnea syndrome,
  • Inability to give written informed consent,
  • Chronic diseases,
  • moderate to severe left ventricular hypertrophy :> 109 g / m2 in women and> 132 g / m2 in men and parietal thickness > 13mm.
  • poor glycemic control (HbA1c > 9%)
  • poor echogenicity
  • severe autonomic or peripheral neuropathy,
  • Severe diabetic retinopathy,
  • Advanced Diabetic nephropathy (defined by documented proteinuria and/or renal failure).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437421


Locations
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France
Hospital Henri Duffaut Recruiting
Avignon, Paca, France, 84000
Contact: Falah Aboukhoudir, MD    +33622085526    faboukhoudir@ch-avignon.fr   
Sponsors and Collaborators
University of Avignon
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Responsible Party: University of Avignon
ClinicalTrials.gov Identifier: NCT03437421    
Other Study ID Numbers: UAPV-022018-SFC
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Avignon:
myocardial function
vitamin D
stress echocardiography
diabetes
Additional relevant MeSH terms:
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Vitamin D Deficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents