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Vitamin D Supplementation and and Glycemic Indexes

Primary Purpose

Deficiency, Vitamin D, Insulin Resistance

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

About this trial

This is an interventional prevention trial for Deficiency, Vitamin D focused on measuring Vitamin D, HOMA-IR, Glucose, HbA1C, insulin resistance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D group

    Placebo group

    Arm Description

    The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)

    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.

    Outcomes

    Primary Outcome Measures

    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.
    25 (OH)D
    Vitamin D

    Secondary Outcome Measures

    BMI
    Body mass Index
    FBG
    Fasting blood glucose
    FBI
    Fasting Blood inslin
    HbA1C
    Glycated hemoglobin
    Total cholesterol
    Total cholesterol
    LDL cholesterol
    LDL cholesterol
    HDL cholesterol
    HDL cholesterol

    Full Information

    First Posted
    March 13, 2018
    Last Updated
    March 26, 2018
    Sponsor
    Université d'Auvergne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03478475
    Brief Title
    Vitamin D Supplementation and and Glycemic Indexes
    Official Title
    Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2, 2015 (Actual)
    Primary Completion Date
    September 19, 2015 (Actual)
    Study Completion Date
    September 19, 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deficiency, Vitamin D, Insulin Resistance
    Keywords
    Vitamin D, HOMA-IR, Glucose, HbA1C, insulin resistance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This was a randomized, controlled, double blind study. Participants were randomized into 2 groups; the vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) and the placebo group who also received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. The treatment was led for a period of 6 months.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.
    Allocation
    Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D group
    Arm Type
    Experimental
    Arm Description
    The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cholecalciferol (Euro-Pharm International, Canada)
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
    Primary Outcome Measure Information:
    Title
    HOMA-IR
    Description
    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.
    Time Frame
    6 months
    Title
    25 (OH)D
    Description
    Vitamin D
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    BMI
    Description
    Body mass Index
    Time Frame
    6 months
    Title
    FBG
    Description
    Fasting blood glucose
    Time Frame
    6 months
    Title
    FBI
    Description
    Fasting Blood inslin
    Time Frame
    6 months
    Title
    HbA1C
    Description
    Glycated hemoglobin
    Time Frame
    6 months
    Title
    Total cholesterol
    Description
    Total cholesterol
    Time Frame
    6 months
    Title
    LDL cholesterol
    Description
    LDL cholesterol
    Time Frame
    6 months
    Title
    HDL cholesterol
    Description
    HDL cholesterol
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30379314
    Citation
    El Hajj C, Chardigny JM, Boirie Y, Yammine K, Helou M, Walrand S. Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: A Randomized Controlled Trial. J Nutr Health Aging. 2018;22(9):1128-1132. doi: 10.1007/s12603-018-1083-8.
    Results Reference
    derived

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