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NCT03356873 Clinical Trial

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

Insulin Resistance Clinical Trial

— VICOX  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03356873
Other study ID # DIA-981-13/14-1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date July 18, 2022

Study information
Verified date March 2023
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 31
Est. completion date July 18, 2022
Est. primary completion date July 18, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in anti-oxidant capacity measured in serum Change in serum anti-oxidant capacity after one month One month
Secondary Change in homeostasis model assessment (HOMA) index measured in serum Change in homeostasis model assessment (HOMA) index after one month One month
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