Effect of Vitamin D Supplementation on Inflammatory Markers

Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Type2 Diabetes
• Intervention / Treatment: Dietary supplement: cholecalciferol (Euro-Pharm International, Canada); Dietary supplement: Placebo tablet

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 64
    • Saint Charles Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; 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.	Dietary supplement: cholecalciferol (Euro-Pharm International, Canada); 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
Placebo Comparator: Placebo group; 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	Dietary supplement: Placebo tablet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Université d'Auvergne
• Investigators: Study Director: Cynthia E Hajj, PhD, Dr

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): June 7, 2018
• Study Completion (Actual): July 9, 2018

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: vitamin D, type 2 diabetes, inflammation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Diabetes Mellitus, Type 2; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 222222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The plan will be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No