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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03356873
Acronym
VICOX
Enrollment
31
Registered
2017-11-29
Start date
2017-09-01
Completion date
2022-07-18
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGVitamin D

Vitamin D supplementation

OTHERPlacebo

Placebo

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in anti-oxidant capacity measured in serumOne monthChange in serum anti-oxidant capacity after one month

Secondary

MeasureTime frameDescription
Change in homeostasis model assessment (HOMA) index measured in serumOne monthChange in homeostasis model assessment (HOMA) index after one month

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026