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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.
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months. |
|
| Placebo group | Placebo Comparator | Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (Euro-Pharm International, Canada) | Dietary Supplement | The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline fasting blood glucose (FBG) at 6 months | FASTING BLOOD GLUCOSE | baseline and after 6 months of intervention |
| 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 |
| Change from Baseline C-reactive protein (CRP) at 6 months | C-reactive protein | baseline and after 6 months of intervention |
| Change from Baseline Interleukin-6 (IL-6) at 6 months | Interleukin-6 | baseline and after 6 months of intervention |
| Change from Baseline TNF-alpha at 6 months | TNF-alpha | baseline and after 6 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline weight at 6 months | weight change | baseline and after 6 months of intervention |
| Change from Baseline Body Mass Index (BMI) at 6 months | Body mass index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia E Hajj, PhD | Dr | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Charles Hospital | Beirut | 64 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29945132 | Background | 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. | |
| 30159285 | Background |
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The plan will be shared upon request
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
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Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.
| Placebo tablet | Dietary Supplement | The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months |
|
| baseline and after 6 months of intervention |
| Change from Baseline waist circumference at 6 months | Waist circumference change | baseline and after 6 months of intervention |
| Change from Baseline Percentage of fat at 6 months | Percentage of fat | baseline and after 6 months of intervention |
| Change from Baseline Parathyroid hormone (PTH) at 6 months | Parathyroid hormone | baseline and after 6 months of intervention |
| 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. |
| 32659891 | Derived | El Hajj C, Walrand S, Helou M, Yammine K. Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial. Nutrients. 2020 Jul 9;12(7):2033. doi: 10.3390/nu12072033. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |