Vitamin D Supplementation and Glycemic Outcomes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: normal-weight adult subjects<br>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)<br>* 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.<br>|
| Other: overweight adult subjects<br>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)<br>* 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.<br>|
| Other: normal-weight elderly<br>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)<br>* 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.<br>|
| Other: overweight elderly<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Glucose, HbA1C, Insulin resistance, Blood lipids