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Vitamin D Supplementation and Glycemic Outcomes

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cholecalciferol (Euro-Pharm International, Canada)
Sponsored by
Université d'Auvergne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Vitamin D, Glucose, HbA1C, Insulin resistance, Blood lipids

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    normal-weight adult subjects

    overweight adult subjects

    normal-weight elderly

    overweight elderly

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Fasting blood glucose (mmol/l)
    Change in Fasting blood glucose in mmol/l
    HbA1C (%)
    Change in HbA1C (%)
    HOMA-IR
    Change in HOMA-IR
    Fasting Insulin (mIU/L)
    Change in Fasting Insulin (mIU/L)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2016
    Last Updated
    October 21, 2016
    Sponsor
    Université d'Auvergne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02942732
    Brief Title
    Vitamin D Supplementation and Glycemic Outcomes
    Official Title
    Effect of Treating Vitamin D Deficiency on Glucose Homeostasis and Metabolic Markers in Apparently Healthy, Young or Aged, Normal-weight or Obese Lebanese People
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Université d'Auvergne

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance
    Keywords
    Vitamin D, Glucose, HbA1C, Insulin resistance, Blood lipids

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    normal-weight adult subjects
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    overweight adult subjects
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    normal-weight elderly
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    overweight elderly
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cholecalciferol (Euro-Pharm International, Canada)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Fasting blood glucose (mmol/l)
    Description
    Change in Fasting blood glucose in mmol/l
    Time Frame
    Baseline and 6 months
    Title
    HbA1C (%)
    Description
    Change in HbA1C (%)
    Time Frame
    Baseline and 6 months
    Title
    HOMA-IR
    Description
    Change in HOMA-IR
    Time Frame
    Baseline and 6 months
    Title
    Fasting Insulin (mIU/L)
    Description
    Change in Fasting Insulin (mIU/L)
    Time Frame
    Baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephane Walrand, PhD
    Organizational Affiliation
    Auvergne Univeristy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19125756
    Citation
    Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. doi: 10.1111/j.1464-5491.2008.02636.x.
    Results Reference
    result
    PubMed Identifier
    17389701
    Citation
    Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
    Results Reference
    result

    Learn more about this trial

    Vitamin D Supplementation and Glycemic Outcomes

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