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

NCT03356873 | Terminated

• 1 other identifier: DIA-981-13/14-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in anti-oxidant capacity measured in serum

  Change in serum anti-oxidant capacity after one month

  One month

Secondary Outcomes (1)

• Change in homeostasis model assessment (HOMA) index measured in serum

  One month

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Identical placebo capsules, 20 capsules per week during four weeks

Other: Placebo

Interventions

Vitamin D DRUG

Vitamin D supplementation

Also known as: Vitamin D3

Active

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Glucose Intolerance; Insulin Resistance

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 29, 2017
• Study Start: September 1, 2017
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

ME (1)