Effect of Vitamin D Supplementation on Inflammatory Markers

Université d'Auvergne

Status: Completed

Conditions: Type2 Diabetes; Vitamin D Deficiency

Treatments: Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada); Dietary Supplement: Placebo tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03782805

222222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 60 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo tablet