Supplementation with Vitamins D3 and K2 for Bone Mineralization in Type 2 Diabetes Mellitus Patients
This study aims to evaluate the effects of Vitamins D3 and K2 supplementation on bone mineralization in individuals with Type 2 Diabetes Mellitus, by observing changes in insulin and non-carboxylated osteocalcin serum levels.
Supplementation with Vitamin D3 y K2
Bone Diseases+8
+ Bone Diseases, Metabolic
+ Diabetes Mellitus
Supportive Care Study
Summary
Study start date: February 14, 2017
Actual date on which the first participant was enrolled.This study focuses on individuals with Type 2 diabetes, a condition marked by high blood sugar levels, which is a leading cause of death. People with Type 2 diabetes often face related health issues, such as bone demineralization, which can lead to a decrease in bone density. This bone weakening could be linked to the levels of Non-carboxylated Osteocalcin and Insulin, two molecules that play a role in bone mineralization. The study aims to address this issue as many people do not get enough vitamins, specifically Vitamins D3 and K, in their daily diet. These vitamins are important for maintaining bone health. The study proposes to give these vitamins as supplements to patients with Type 2 diabetes to prevent a decrease in bone density and potentially improve their health outcomes. Participants in the study are from the Western part of the country and undergo a comprehensive clinical evaluation, including a detailed medical history. They are then randomly assigned to one of three groups. The first group receives Vitamin D3 and a placebo, the second group receives Vitamin K2 and a placebo, and the third group receives both Vitamin D3 and K2. Blood samples are collected and the levels of Non-carboxylated Osteocalcin and Insulin are measured before and after the supplementation. The study also measures cholesterol and triglyceride levels, and calculates the HOMA index for insulin resistance. Participants are asked to keep a daily record of their vitamin intake and any adverse reactions. The results of the study are shared with each participant at the end of the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location