Completed

Supplementation with Vitamins D3 and K2 for Bone Mineralization in Type 2 Diabetes Mellitus Patients

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Study Aim

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.

What is being tested

Supplementation with Vitamin D3 y K2

Dietary Supplement
Who is being recruted

Bone Diseases+8

+ Bone Diseases, Metabolic

+ Diabetes Mellitus

From 30 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2017
See protocol details

Summary

Principal SponsorUniversity of Guadalajara
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEffect of Supplementation With Vitamins D3 and K2 in Non-carboxyled Osteocalcine and Insulin Serum Levels in Patients With Diabetes Mellitus Type 2
NCT04041492
Principal SponsorUniversity of Guadalajara
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Bone DiseasesBone Diseases, MetabolicDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Originating and residents of Western Mexico

Both genres

Age of 30-75 years

Diagnosis of DM2 (ADA Criteria) of at least 5 years of evolution

Show More Criteria

5 exclusion criteria prevent from participating
Use of active drugs for bone mineralization

Pregnancy

Lactation

Creatinine or transaminase more than double the upper limit

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Vitamin D3 1000UI + Placebo (Calcined Magnesia).

Group II

Experimental
Vitamin K2 100 mcg + Placebo (Calcined Magnesia).

Group III

Active Comparator
Vitamin D3 1000UI + Vitamin K2 100 mcg

Study 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

Suspended

Julio Iván Aguayo

Guadalajara, MexicoOpen Julio Iván Aguayo in Google Maps
CompletedOne Study Center