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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Oxidative Stress
• Vitamin D Deficiency

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