Effect of Vitamin D on Inflammatory Markers in Type 2 Diabetes Mellitus in Mexico.

NCT06993064 | Active Not Recruiting

• 1 other identifier: 7236/2025CIB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 Diabetes Mellitus (T2DM) is a very common disease in Mexico, and its long-term complications affect years of healthy life and a high cost in treatmenty. T2DM is a chronic disease associated to inflammation. We aim to establish if Vitamin D may help decrease this inflammation and improve the condition in adults with T2DM. Patients included in the study will have to take 1 pill/day of vitamin D for six months. The investigators will measure weight, height, waist and hip circumference, systolic and dyastolic blood pressure; obtain dietary and clinical information, as well as a 10mL blood sample from the arm, for laboratory analyses, finger-prick blood sample for glucose at the beginning and end of the study; ´plus a finger-prick blood samplo for the initial vitamin D status. The study is completely free for the participants and they may withdraw their consent at any time without any consequences. Participants will have to attend the clinic at the beginning and every two months until the end, to receive their supplement (total 4 appointments). They will receive a phone call once a week to remind you to take your pills. They will be handed your results at the end of the study.

Conditions

Type 2 Diabetes Melitus; Inflammation Biomarkers

Keywords

Type 2 diabetes mellitus; vitamin D supplemention; inflammatory markers

Outcome Measures

Primary Outcomes (5)

• Effect on glycemia

  Measurement of glucose at baseline and 6 months

  6 months

• Effect on C-reactive protein

  Measurement of C-reactive protein (CRP) before and after supplementation

  6 months

• Effect on glycosilated hemoglobin

  Measurement of Hb1Ac at baseline and 6 months

  6 months

• Effect on insulin

  Measurement of insulin at baseline and 6 months

  6 months

• Effect on Interleukin 6

  Effect on IL-6 before and after supplementation

  6 months

Secondary Outcomes (2)

• Effect on Total Cholesterol

  6 months

• Effect on HDL Cholesterol

  6 months

Other Outcomes (2)

• Changes on Vitamin D status

  6 months

• Vitamin D dietary intake

  6 months

Study Arms (1)

Measurement of markers before and after vitamin D supplementation

OTHER

Measurement of markers before and after vitamin D supplementation

Dietary Supplement: 4000 IU of Vitamin D3

Interventions

4000 IU of Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D supplementation in Mexican subjects with Type 2 Diabetes Mellitus

Measurement of markers before and after vitamin D supplementation

Eligibility Criteria

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

You may qualify if:

• subjects with medically diagnosed type 2 diabetes mellitus
• controlled with diet and/or metformin
• less than 5 years of evolution
• children and grandchildren of Mexican origin

You may not qualify if:

• Subjects that do not complete the study
• Subjects that do not take the supplement

Sponsors & Collaborators

• Universidad Autonoma del Estado de Mexico: lead

Study Sites (1)

Faculty of Medicine

Toluca, 50180, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mariana Ortíz Reynoso, DPharm

  Secretary of Research and Graduate Studies. Universidad Autónoma del Estado de México.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Science

Model Details: Longitudinal study of 40 adults with Type 2 Diabetes Mellitus, with six-month follow-up of supplementation with 4000 IU of Vitamin D3/day, with pre and post measurements.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start date: April 2026 End date: April 2028
• Access Criteria: The data will be available upon request to the principal investigator.

Locations

ME (1)