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Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance

NCT01779908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-07-24

No results posted yet for this study

Summary

Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will have abdominal obesity and at least one factor associated with insulin resistance. Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism, the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be correlated with changes in blood markers associated with insulin sensitivity \[hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin\].

This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D increases insulin sensitivity.

Conditions

  • Vitamin D-deficient
  • Insulin-resistant

Interventions

DIETARY_SUPPLEMENT

Vitamin D

OTHER

Placebo

Sponsors & Collaborators

  • Canadian Diabetes Association

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Claudia Gagnon, Dr. · CHU de Québec Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-06-02
Completion
2020-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01779908 on ClinicalTrials.gov