Vitamin D Supplementation and Glycemic Outcomes

Insulin Resistance Clinical Trial

Official title:

Effect of Treating Vitamin D Deficiency on Glucose Homeostasis and Metabolic Markers in Apparently Healthy, Young or Aged, Normal-weight or Obese Lebanese People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942732
• Other study ID #: UAuvergne
• Status: Completed
• Phase: N/A
• First received: October 16, 2016
• Last updated: October 21, 2016
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2016
• Source: Université d'Auvergne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The investigators examined the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon.

Description:

A low serum 25-hydroxyvitamin D (25(OH)D) concentration has been shown to correlate with higher fasting blood glucose (FBG) and insulin levels and other metabolic abnormalities like dyslipidemia. Previous studies suggest that vitamin D supplementation is able to improve insulin sensitivity and metabolic markers. The aim of the study was to investigate the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon. Participants (n= 180; 93 men and 87 women) deficient in vitamin D were recruited from Saint Charles Hospital, Beirut, Lebanon. Four groups were recruited: normal-weight adults (n=30, age ≤ 65 years and BMI < 25 kg/m²), overweight adults (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and BMI < 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²).

Participants received a supplement of 10,000 IU cholecalciferol to be taken three times per week for a period of 6 months. Glucose homeostasis and metabolic markers were measured at start of treatment, at 3 months and at 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included

Exclusion Criteria:

• Participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• cholecalciferol (Euro-Pharm International, Canada)
All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université d'Auvergne

References & Publications (2)

Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. do — View Citation

Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. Epub 2007 Mar 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose (mmol/l)	Change in Fasting blood glucose in mmol/l	Baseline and 6 months	No
Primary	HbA1C (%)	Change in HbA1C (%)	Baseline and 6 months	No
Primary	HOMA-IR	Change in HOMA-IR	Baseline and 6 months	No
Primary	Fasting Insulin (mIU/L)	Change in Fasting Insulin (mIU/L)	Baseline and 6 months	No