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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2022-07-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin D Deficiency Glucose Intolerance Oxidative Stress Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Vitamin D supplementation

Placebo

Identical placebo capsules, 20 capsules per week during four weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Vitamin D

Vitamin D supplementation

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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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