Clinical trial NCT03478475: 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
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency, Vitamin D
Insulin Resistance
Keywords: Vitamin D
HOMA-IR
Glucose
HbA1C
insulin resistance
Lead sponsor: Université d'Auvergne
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: HOMA-IR
timeFrame: 6 months
measure: 25 (OH)D
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 6 months
measure: FBG
timeFrame: 6 months
measure: FBI
timeFrame: 6 months
measure: HbA1C
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: HDL cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.