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Vitamin D Supplementation and and Glycemic Indexes

Not Applicable
Completed
Conditions
Insulin Resistance
Deficiency, Vitamin D
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.

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
Primary Outcome Measures
NameTimeMethod
25 (OH)D6 months

Vitamin D

HOMA-IR6 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
NameTimeMethod
HbA1C6 months

Glycated hemoglobin

LDL cholesterol6 months

LDL cholesterol

FBG6 months

Fasting blood glucose

Total cholesterol6 months

Total cholesterol

HDL cholesterol6 months

HDL cholesterol

FBI6 months

Fasting Blood inslin

BMI6 months

Body mass Index

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