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Vitamin C, D, and Zinc Supplementation Impact on Immune and Inflammatory Response in Type 2 Diabetes

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Study Aim

This study aims to evaluate the impact of Vitamin C, D, and Zinc supplementation on your immune and inflammatory response, specifically measuring changes in glycemia, glycosylated Hemoglobin (Hb1Ac), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and plasma insulin levels over 12 and 24 weeks, if you have Type 2 Diabetes.

What is being tested

Vitamin Supplement

+ Placebo

Dietary SupplementOther
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 25 to 55 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorUniversidad Autonoma del Estado de Mexico
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 9, 2020

Actual date on which the first participant was enrolled.

This study focuses on understanding the impact of Vitamin C, Vitamin D, and Zinc supplementation on the immune and inflammatory processes in individuals with Type 2 Diabetes in Mexico. The goal is to see if these supplements can improve the management of diabetes, a condition where the body struggles to regulate blood sugar levels. This research is important as it could potentially lead to new ways of managing diabetes, enhancing the quality of life for those affected by this condition. During the 24-week study, participants are randomly assigned to either a supplement group or a placebo group. The supplement group receives a daily dose of 1000 mg Vitamin C, 400 IU Vitamin D, and 10 mg of Zinc. Neither the participants nor the researchers know who is receiving the supplements or the placebo, ensuring the results are unbiased. The study measures changes in blood sugar levels, glycosylated Hemoglobin (Hb1Ac), insulin resistance, and plasma insulin at the start, 12 weeks, and 24 weeks. These measurements help determine if the supplements are effective in managing diabetes.

Official TitleEffect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico
NCT03734445
Principal SponsorUniversidad Autonoma del Estado de Mexico
Last updated: January 28, 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

120 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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 25 to 55 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

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Between 25 and 55 years of age, as this is the age in which type 2 diabetes mellitus is more prevalent and there is less probability of encountering multiple diseases in the same subjects
Both sexes
Outpatients
BMI ≥ 25
15 exclusion criteria prevent from participating
Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
Severe renal insufficiency.
Nephrolithiasis or history of nephrolithiasis.
Hyperoxaluria.
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

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Effervescent tablets containing Vitamin C, Vitamin D and zinc

Group II

Placebo
Effervescent tablets not containing Vitamin C, Vitamin D and zinc

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 no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers