Vitamin D Supplementation and and Glycemic Indexes

March 26, 2018 updated by: Université d'Auvergne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D group
The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)
Dietary supplement: cholecalciferol (Euro-Pharm International, Canada)
Placebo Comparator: Placebo group
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.
Other: Placebo
Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR
Time Frame: 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.
6 months
25 (OH)D
Time Frame: 6 months
Vitamin D
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL cholesterol
Time Frame: 6 months
LDL cholesterol
6 months
BMI
Time Frame: 6 months
Body mass Index
6 months
FBG
Time Frame: 6 months
Fasting blood glucose
6 months
FBI
Time Frame: 6 months
Fasting Blood inslin
6 months
HbA1C
Time Frame: 6 months
Glycated hemoglobin
6 months
Total cholesterol
Time Frame: 6 months
Total cholesterol
6 months
HDL cholesterol
Time Frame: 6 months
HDL cholesterol
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université d'Auvergne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2015

Primary Completion (Actual)

September 19, 2015

Study Completion (Actual)

September 19, 2015

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSCC012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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