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OpenTrials
Completed

NCT Number: NCT03478475

Vitamin D Supplementation and and Glycemic Indexes

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.

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Key information

Conditions

Deficiency, Vitamin D Avitaminosis Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cholecalciferol (Euro-Pharm International, Canada)

Dietary Supplement

Placebo

Other

Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université d'Auvergne

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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