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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