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

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

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.

Study Overview

• Status: Terminated
• Conditions: Vitamin D Deficiency; Insulin Resistance; Glucose Intolerance; Oxidative Stress
• Intervention / Treatment: Other: Placebo; Drug: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)	Drug: Vitamin D; Vitamin D supplementation; Other Names: Vitamin D3
Placebo Comparator: Placebo; Identical placebo capsules, 20 capsules per week during four weeks	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anti-oxidant capacity measured in serum	Change in serum anti-oxidant capacity after one month	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in homeostasis model assessment (HOMA) index measured in serum	Change in homeostasis model assessment (HOMA) index after one month	One month

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nutrition Disorders; Hyperinsulinism; Avitaminosis; Deficiency Diseases; Malnutrition; Hyperglycemia; Vitamin D Deficiency; Glucose Intolerance; Insulin Resistance; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: DIA-981-13/14-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No