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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Terminated

Conditions: Vitamin D Deficiency; Insulin Resistance; Oxidative Stress; Glucose Intolerance

Treatments: Drug: Vitamin D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03356873

DIA-981-13/14-1

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

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

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

Identical placebo capsules, 20 capsules per week during four weeks

Treatment:

Other: Placebo