Vitamin D Supplementation and and Glycemic Indexes

NCT03478475 | Completed DMC

• 1 other identifier: SSCC012
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deficiency, Vitamin D; Insulin Resistance

Keywords

Vitamin D; HOMA-IR; Glucose; HbA1C; insulin resistance

Outcome Measures

Primary Outcomes (2)

• 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

• 25 (OH)D

  Vitamin D

  6 months

Secondary Outcomes (7)

• BMI

  6 months

• FBG

  6 months

• FBI

  6 months

• HbA1C

  6 months

• Total cholesterol

  6 months

Study Arms (2)

Vitamin D group

EXPERIMENTAL

The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)

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

Placebo group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

cholecalciferol (Euro-Pharm International, Canada) DIETARY_SUPPLEMENT

Vitamin D group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université d'Auvergne: lead

Related Publications (1)

• 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.

  PMID: 30379314 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 27, 2018
• Study Start: July 2, 2015
• Primary Completion: September 19, 2015
• Study Completion: September 19, 2015
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share