Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)

Overview

The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.

Full Title of Study: “Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Impaired Glucose Tolerance: A Randomized, Double-blind, Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 18, 2022

Interventions

  • Drug: Vitamin D
    • Vitamin D supplementation
  • Other: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Active
    • Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)
  • Placebo Comparator: Placebo
    • Identical placebo capsules, 20 capsules per week during four weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in anti-oxidant capacity measured in serum
    • Time Frame: One month
    • Change in serum anti-oxidant capacity after one month

Secondary Measures

  • Change in homeostasis model assessment (HOMA) index measured in serum
    • Time Frame: One month
    • Change in homeostasis model assessment (HOMA) index after one month

Participating in This Clinical Trial

Inclusion Criteria

  • Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load > or equal 140 mg/dl), 25-hydroxy vitamin D concentration < or equal 15 ng/ml Exclusion Criteria:

  • Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Provider of Information About this Clinical Study
    • Sponsor

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