Vitamin D Supplementation and and Glycemic Indexes

Université d'Auvergne

Status: Completed

Conditions: Deficiency, Vitamin D; Insulin Resistance

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03478475

SSCC012

Details and patient eligibility

About

Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.

Full description

A low serum 25-hydroxyvitamin D [(25(OH) D)] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.

Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.

Enrollment: 115 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus

Exclusion criteria

patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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115 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)

Treatment:

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

Placebo group

Placebo Comparator group

Description:

The placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving.

Treatment:

Other: Placebo