Vitamin D Supplementation and Glycemic Outcomes

October 21, 2016 updated by: Université d'Auvergne

Effect of Treating Vitamin D Deficiency on Glucose Homeostasis and Metabolic Markers in Apparently Healthy, Young or Aged, Normal-weight or Obese Lebanese People

The investigators examined the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A low serum 25-hydroxyvitamin D (25(OH)D) concentration has been shown to correlate with higher fasting blood glucose (FBG) and insulin levels and other metabolic abnormalities like dyslipidemia. Previous studies suggest that vitamin D supplementation is able to improve insulin sensitivity and metabolic markers. The aim of the study was to investigate the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon. Participants (n= 180; 93 men and 87 women) deficient in vitamin D were recruited from Saint Charles Hospital, Beirut, Lebanon. Four groups were recruited: normal-weight adults (n=30, age ≤ 65 years and BMI < 25 kg/m²), overweight adults (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and BMI < 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²).

Participants received a supplement of 10,000 IU cholecalciferol to be taken three times per week for a period of 6 months. Glucose homeostasis and metabolic markers were measured at start of treatment, at 3 months and at 6 months.

Study Type

Interventional

Enrollment (Actual)

180

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included

Exclusion Criteria:

  • Participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: normal-weight adult subjects
normal-weight adult subjects (n=30, age ≤ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Dietary supplement: cholecalciferol (Euro-Pharm International, Canada)
All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Other: overweight adult subjects
overweight adult subjects (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Dietary supplement: cholecalciferol (Euro-Pharm International, Canada)
All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Other: normal-weight elderly
normal-weight elderly (n=60, age ≥ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Dietary supplement: cholecalciferol (Euro-Pharm International, Canada)
All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Other: overweight elderly
overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
Dietary supplement: cholecalciferol (Euro-Pharm International, Canada)
All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose (mmol/l)
Time Frame: Baseline and 6 months
Change in Fasting blood glucose in mmol/l
Baseline and 6 months
HbA1C (%)
Time Frame: Baseline and 6 months
Change in HbA1C (%)
Baseline and 6 months
HOMA-IR
Time Frame: Baseline and 6 months
Change in HOMA-IR
Baseline and 6 months
Fasting Insulin (mIU/L)
Time Frame: Baseline and 6 months
Change in Fasting Insulin (mIU/L)
Baseline and 6 months

Collaborators and Investigators

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

Sponsor

Université d'Auvergne

Investigators

  • Study Director: Stephane Walrand, PhD, Auvergne Univeristy

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

February 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 16, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAuvergne

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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