Vitamin D Supplementation and and Glycemic Indexes

Not Applicable

Completed

• Conditions: Insulin Resistance; Deficiency, Vitamin D
• Interventions: Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada); Other: Placebo

• Registration Number: NCT03478475
• Lead Sponsor: Université d'Auvergne

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07-02
• Primary Completion: 2015-09-19
• Study Completion: 2015-09-19
• Status Verified: 2018-03
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-26
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
25 (OH)D	6 months	Vitamin D
HOMA-IR	6 months	The HOMA-IR formula was as following: HOMA-IR = \[insulin (mU/L) × glucose (mg/dL)\]/22.5 where IR is the mutual of percentage sensitivity with a normal value of 1.0.

Secondary Outcome Measures

Name	Time	Method
FBI	6 months	Fasting Blood inslin
BMI	6 months	Body mass Index
HbA1C	6 months	Glycated hemoglobin
LDL cholesterol	6 months	LDL cholesterol
FBG	6 months	Fasting blood glucose
Total cholesterol	6 months	Total cholesterol
HDL cholesterol	6 months	HDL cholesterol