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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Unknown status

CT.gov ID

NCT03356873

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Glucose Intolerance Oxidative Stress Insulin Resistance	Drug: Vitamin D Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)	Drug: Vitamin D Vitamin D supplementation Other Names: Vitamin D3
Placebo Comparator: Placebo Identical placebo capsules, 20 capsules per week during four weeks	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Active

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

Drug: Vitamin D

Vitamin D supplementation

Other Names:

Vitamin D3

Placebo Comparator: Placebo

Identical placebo capsules, 20 capsules per week during four weeks

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change in anti-oxidant capacity measured in serum [One month]
Change in serum anti-oxidant capacity after one month

Secondary Outcome Measures

Change in homeostasis model assessment (HOMA) index measured in serum [One month]
Change in homeostasis model assessment (HOMA) index after one month

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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