Deficiency, Vitamin D, Insulin Resistance
Conditions
Keywords
Vitamin D, HOMA-IR, Glucose, HbA1C, insulin resistance
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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol (Euro-Pharm International, Canada)
OTHERPlacebo
Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
Sponsors
Université d'Auvergne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | 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. |
| 25 (OH)D | 6 months | Vitamin D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FBI | 6 months | Fasting Blood inslin |
| HbA1C | 6 months | Glycated hemoglobin |
| BMI | 6 months | Body mass Index |
| LDL cholesterol | 6 months | LDL cholesterol |
| HDL cholesterol | 6 months | HDL cholesterol |
| Total cholesterol | 6 months | Total cholesterol |
| FBG | 6 months | Fasting blood glucose |
Outcome results
None listed