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

Primary Purpose

Vitamin D Deficiency, Glucose Intolerance, Oxidative Stress

Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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

Identical placebo capsules, 20 capsules per week during four weeks

Outcomes

Primary Outcome Measures

Change in anti-oxidant capacity measured in serum
Change in serum anti-oxidant capacity after one month

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2017
Last Updated
March 13, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT03356873
Brief Title
Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)
Acronym
VICOX
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID19
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Glucose Intolerance, Oxidative Stress, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo capsules, 20 capsules per week during four weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D supplementation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in anti-oxidant capacity measured in serum
Description
Change in serum anti-oxidant capacity after one month
Time Frame
One month
Secondary Outcome Measure Information:
Title
Change in homeostasis model assessment (HOMA) index measured in serum
Description
Change in homeostasis model assessment (HOMA) index after one month
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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