Vitamin D Deficiency Clinical Trial
Official title:
Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
NCT number | NCT03782805 |
Other study ID # | 222222 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2018 |
Est. completion date | July 9, 2018 |
Verified date | December 2018 |
Source | Université d'Auvergne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
Status | Completed |
Enrollment | 88 |
Est. completion date | July 9, 2018 |
Est. primary completion date | June 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 72 Years |
Eligibility |
Inclusion Criteria: - Subjects deficient in vitamin D - Subjects having type 2 diabetes - Non-obese subjects Exclusion Criteria: - Subjects having hyperparathyroidism - Subjects suffering from hepatic disease / kidney disease |
Country | Name | City | State |
---|---|---|---|
Lebanon | Saint Charles Hospital | Beirut |
Lead Sponsor | Collaborator |
---|---|
Université d'Auvergne |
Lebanon,
Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018. — View Citation
Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline fasting blood glucose (FBG) at 6 months | FASTING BLOOD GLUCOSE | baseline and after 6 months of intervention | |
Primary | Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months | Homeostatic Model Assessment of Insulin Resistance | baseline and after 6 months of intervention | |
Primary | Change from Baseline C-reactive protein (CRP) at 6 months | C-reactive protein | baseline and after 6 months of intervention | |
Primary | Change from Baseline Interleukin-6 (IL-6) at 6 months | Interleukin-6 | baseline and after 6 months of intervention | |
Primary | Change from Baseline TNF-alpha at 6 months | TNF-alpha | baseline and after 6 months of intervention | |
Secondary | Change from Baseline weight at 6 months | weight change | baseline and after 6 months of intervention | |
Secondary | Change from Baseline Body Mass Index (BMI) at 6 months | Body mass index | baseline and after 6 months of intervention | |
Secondary | Change from Baseline waist circumference at 6 months | Waist circumference change | baseline and after 6 months of intervention | |
Secondary | Change from Baseline Percentage of fat at 6 months | Percentage of fat | baseline and after 6 months of intervention | |
Secondary | Change from Baseline Parathyroid hormone (PTH) at 6 months | Parathyroid hormone | baseline and after 6 months of intervention |
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