Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 115
- Primary Endpoint
- 25 (OH)D
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Vitamin D group
The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)
Intervention: cholecalciferol (Euro-Pharm International, Canada) (Dietary Supplement)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
25 (OH)D
Time Frame: 6 months
Vitamin D
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.
Secondary Outcomes
- BMI(6 months)
- HbA1C(6 months)
- LDL cholesterol(6 months)
- FBG(6 months)
- Total cholesterol(6 months)
- HDL cholesterol(6 months)
- FBI(6 months)