Clinical trial NCT03782805: Effect of Vitamin D Supplementation on Inflammatory Markers
Official title: Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Type2 Diabetes
Keywords: vitamin D, type 2 diabetes, inflammation
Lead sponsor: Université d'Auvergne
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline fasting blood glucose (FBG) at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline C-reactive protein (CRP) at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline Interleukin-6 (IL-6) at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline TNF-alpha at 6 months
timeFrame: baseline and after 6 months of intervention
Secondary outcomes:
measure: Change from Baseline weight at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline Body Mass Index (BMI) at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline waist circumference at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline Percentage of fat at 6 months
timeFrame: baseline and after 6 months of intervention
measure: Change from Baseline Parathyroid hormone (PTH) at 6 months
timeFrame: baseline and after 6 months of intervention
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Charles Hospital
Study officials:
affiliation: Dr
name: Cynthia E Hajj, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.