Effect of Vitamin D Supplementation on Inflammatory Markers

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Type2 Diabetes
• Interventions: Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada); Dietary Supplement: Placebo tablet

• Registration Number: NCT03782805
• Lead Sponsor: Université d'Auvergne

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.

Study Timeline

• Study Start: 2018-05-09
• Primary Completion: 2018-06-07
• Study Completion: 2018-07-09
• Status Verified: 2018-12
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	cholecalciferol (Euro-Pharm International, Canada)	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 tablet	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline fasting blood glucose (FBG) at 6 months	baseline and after 6 months of intervention	FASTING BLOOD GLUCOSE
Change from Baseline C-reactive protein (CRP) at 6 months	baseline and after 6 months of intervention	C-reactive protein
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months	baseline and after 6 months of intervention	Homeostatic Model Assessment of Insulin Resistance
Change from Baseline Interleukin-6 (IL-6) at 6 months	baseline and after 6 months of intervention	Interleukin-6
Change from Baseline TNF-alpha at 6 months	baseline and after 6 months of intervention	TNF-alpha

Secondary Outcome Measures

Name	Time	Method
Change from Baseline weight at 6 months	baseline and after 6 months of intervention	weight change
Change from Baseline Body Mass Index (BMI) at 6 months	baseline and after 6 months of intervention	Body mass index
Change from Baseline waist circumference at 6 months	baseline and after 6 months of intervention	Waist circumference change
Change from Baseline Parathyroid hormone (PTH) at 6 months	baseline and after 6 months of intervention	Parathyroid hormone
Change from Baseline Percentage of fat at 6 months	baseline and after 6 months of intervention	Percentage of fat

Trial Locations

Locations (1)

Saint Charles Hospital; 🇱🇧 Beirut, Lebanon