Vitamin D Supplementation and and Glycemic Indexes

Insulin Resistance Clinical Trial

Official title:

Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478475
• Other study ID #: SSCC012
• Status: Completed
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 26, 2018
• Start date: July 2, 2015
• Est. completion date: September 19, 2015

Study information

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

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 19, 2015
• Est. primary completion date: September 19, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• Deficiency, Vitamin D
• Insulin Resistance
• Vitamin D Deficiency

Intervention

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

Other:
• Placebo
Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université d'Auvergne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR	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.	6 months
Primary	25 (OH)D	Vitamin D	6 months
Secondary	BMI	Body mass Index	6 months
Secondary	FBG	Fasting blood glucose	6 months
Secondary	FBI	Fasting Blood inslin	6 months
Secondary	HbA1C	Glycated hemoglobin	6 months
Secondary	Total cholesterol	Total cholesterol	6 months
Secondary	LDL cholesterol	LDL cholesterol	6 months
Secondary	HDL cholesterol	HDL cholesterol	6 months