Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Supplementation and and Glycemic Indexes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478475
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Université d'Auvergne

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.

Condition or disease Intervention/treatment Phase
Deficiency, Vitamin D Insulin Resistance Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada) Other: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
Actual Study Start Date : July 2, 2015
Actual Primary Completion Date : September 19, 2015
Actual Study Completion Date : September 19, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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%)




Primary Outcome Measures :
  1. 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.

  2. 25 (OH)D [ Time Frame: 6 months ]
    Vitamin D


Secondary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]
    Body mass Index

  2. FBG [ Time Frame: 6 months ]
    Fasting blood glucose

  3. FBI [ Time Frame: 6 months ]
    Fasting Blood inslin

  4. HbA1C [ Time Frame: 6 months ]
    Glycated hemoglobin

  5. Total cholesterol [ Time Frame: 6 months ]
    Total cholesterol

  6. LDL cholesterol [ Time Frame: 6 months ]
    LDL cholesterol

  7. HDL cholesterol [ Time Frame: 6 months ]
    HDL cholesterol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Université d'Auvergne
ClinicalTrials.gov Identifier: NCT03478475     History of Changes
Other Study ID Numbers: SSCC012
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Université d'Auvergne:
Vitamin D
HOMA-IR
Glucose
HbA1C
insulin resistance

Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Avitaminosis
Vitamin D Deficiency
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents