Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03478475
Other study ID # SSCC012
Secondary ID
Status Completed
Phase N/A
First received March 13, 2018
Last updated March 26, 2018
Start date July 2, 2015
Est. completion date September 19, 2015

Study information

Verified date March 2018
Source Université d'Auvergne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date September 19, 2015
Est. primary completion date September 19, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
cholecalciferol (Euro-Pharm International, Canada)

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université d'Auvergne

Outcome

Type Measure Description Time frame Safety issue
Primary HOMA-IR 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. 6 months
Primary 25 (OH)D Vitamin D 6 months
Secondary BMI Body mass Index 6 months
Secondary FBG Fasting blood glucose 6 months
Secondary FBI Fasting Blood inslin 6 months
Secondary HbA1C Glycated hemoglobin 6 months
Secondary Total cholesterol Total cholesterol 6 months
Secondary LDL cholesterol LDL cholesterol 6 months
Secondary HDL cholesterol HDL cholesterol 6 months
See also
  Status Clinical Trial Phase
Completed NCT03142633 - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03383822 - Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT04203238 - Potato Research for Enhancing Metabolic Outcomes N/A
Recruiting NCT03658564 - Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance N/A
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03627104 - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT01809288 - Identifying Risk for Diabetes and Heart Disease in Women
Completed NCT04642482 - Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity Phase 4
Terminated NCT03278236 - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Withdrawn NCT04741204 - Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer Phase 4
Not yet recruiting NCT05540249 - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG N/A