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Effect of Vitamins D3 and K2 in uOc and Insulin Serum Levels in Patients With Diabetes Mellitus

NCT04041492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-08-02

No results posted yet for this study

Summary

Introduction: Patients with DM2 have chronic hyperglycemia derived from a decrease in insulin sensitivity, cause of comorbidities such as bone demineralization, decreasing quality of life and increasing mortality. This could be related to changes in the serum levels of carboxylated Osteocalcin and Insulin, together with the deficit the daily consumption of vitamins D3 and K, which is crucial for the process of mineralization of the bone matrix.

Research question: What is the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus?

Hypothesis: Supplementation with Vitamins D3 and K2 modifies the serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus.

General Objectives: To assess the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated and Non-Carboxylated Osteocalcin in patients with Type 2 Diabetes mellitus.

Material and Methods: Clinical trial, double blind, randomization, 40 patients with DM2, 35-65 years, supplementation (3 months), clinical and laboratory determinations (uOC and Insulin).

* Group 1: Vitamin D3 1000UI + Placebo
* Group 2: Vitamin K2 100 mcg + Placebo
* Group 3 (Positive Control): Vitamins D3 1000UI + K2 100 mcg

Conditions

Interventions

DIETARY_SUPPLEMENT

Supplementation with Vitamin D3 y K2

Supplementation at a dose of 1 capsule every 24 hours x 3 months

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2018-02-14
Completion
2019-02-14

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041492 on ClinicalTrials.gov