Effect of Vitamin D Supplementation on Inflammatory Markers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782805
• Other study ID #: 222222
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: July 9, 2018

Study information

• Verified date: December 2018
• Source: Université d'Auvergne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes
• Vitamin D Deficiency

Intervention

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 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

Locations

Country	Name	City	State
Lebanon	Saint Charles Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Université d'Auvergne

Country where clinical trial is conducted

Lebanon, 

References & Publications (2)

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

Outcome

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