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Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Vitamin Supplement

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus type 2, Vitamin C, Vitamin D, Cinc

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
Severe renal insufficiency.
Nephrolithiasis or history of nephrolithiasis.
Hyperoxaluria.
Hemochromatosis.
Hypercalcaemia.
Hypervitaminosis D.
Using insulin.
Be taking drugs such as desferrioxamine, iron, cyclosporine, indinavir (protease inhibitors), warfarin, thiazide diuretic, orlistat, ion exchange resins (e.g cholestyramine, laxatives (e.g. mineral oil, senna), vitamin d analogues (e.g. ergocalciferol, calcitriol, and topical calcipotriene), tetracycline antibiotics, quinolone antibiotics, penicillamine, biphosphonates, levothyroxine, eltrombopag.
Patients with hypersensitivity to any of the active substance(s) or to any of the excipients.
Hypersensitivity to the by-products including honey, conifers, poplars, Peru balsam, and salicylate.
Intake of probiotics or supplemental vitamin or mineral (vitamin D, C, zinc or calcium) for 4 weeks before the beginning of the study.
Smoking and alcohol consumption (> 40 gr/ day for men and 25 gr/ day for women.
Pregnant or lactating.
Whose parents or grandparents are/were immigrant or of native origin.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin supplement

Placebo

Arm Description

Effervescent tablets containing Vitamin C, Vitamin D and zinc

Effervescent tablets not containing Vitamin C, Vitamin D and zinc

Outcomes

Primary Outcome Measures

Change in glycemia from baseline to 12 and 24 weeks

Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL

Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks

Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage

Change in plasma insulin from baseline to 12 and 24 weeks

Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL

Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks

Calculated from: HOMA-IR = (insulin x glucose)/405

Secondary Outcome Measures

Change in plasma cytokines from baseline to 12 and 24 weeks

Tumor Necrosis Factor alfa (TNFα), Interferon gamma (IFN-γ), Interleukins 1 beta, 4, 6 and 10 (IL-1β, IL4, IL-6, IL10) & transforming growth factor beta (TGF-β), measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL

Change in plasma adipokines from baseline to 12 and 24 weeks

Adiponectin, resistin and leptin, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL

Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks

Apolipoproteins A and B, C-reactive protein, vascular cell adhesion protein (V-CAM), intercellular adhesion molecule (I-CAM), complement proteins C-3 and C-4, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL

Change in lipid profile from baseline to 12 and 24 weeks

Total cholesterol, HDL-, LDL-, Very Low Density Lipoprotein (VLDL)-cholesterol and triacylglycerides, measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL

Changes in markers of oxidative stress from baseline to 12 and 24 weeks

Malondialdehyde (QuantiChromTM), Thiobarbituric acid reactive substances (TBARS Assay Kit), carbonylated proteins (colorimetric), antioxidant capacity (QuantiChromTM Antioxidant Assay Kit), catalase (EnzyChromTM Catalase Assay Kit), superoxide dismutase (EnzyChromTM Superoxide Dismutase Assay Kit) and glutathion peroxidase (metaphosphoric acid SIGMA ALDRICH y EnzyChromTM GSH/GSSG Assay Kit, measured with various commercial kits, in U/μL

Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks

Cluster of desgination 4, 8, 17 and 19 (CD4+, CD8+, CD17+ and CD19+), measured by flow cytometry (Becton Dickinson Facs AriaMR de 6 canales), in percentage

Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks

Analyzed with a Illumina sequencing equipment and Mothur y Stamp softwares, in percentage

Full Information

NCT ID

NCT03734445

First Posted

July 5, 2018

Last Updated

September 30, 2019

Sponsor

Universidad Autonoma del Estado de Mexico

1. Study Identification

Unique Protocol Identification Number

NCT03734445

Brief Title

Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects

Official Title

Effect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 9, 2020 (Anticipated)

Primary Completion Date

January 9, 2020 (Anticipated)

Study Completion Date

March 26, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Autonoma del Estado de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico. According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.

Detailed Description

Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus type 2, Vitamin C, Vitamin D, Cinc

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomly allocated to two groups (vitamin supplement or placebo), with a duration of 24 weeks. Dietary and compliance monthly follow-up and baseline, 12 and 24-week measurements.

Masking

ParticipantInvestigator

Masking Description

Vitamin Supplement and placebo will be packaged by others not including the investigators, code will be kept secret until the end of the trial or unless a secondary effect is registered and merits the opening of the code

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin supplement

Arm Type

Experimental

Arm Description

Effervescent tablets containing Vitamin C, Vitamin D and zinc

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Effervescent tablets not containing Vitamin C, Vitamin D and zinc

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin Supplement

Intervention Description

Subjects will be randomly allocated to a supplementation of vitamin C 1000mg, vitamin D 400 IU and zinc 10 mg or an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Subjects will be randomly allocated to a supplementation of an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding

Primary Outcome Measure Information:

Title

Change in glycemia from baseline to 12 and 24 weeks

Description

Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL

Time Frame

Baseline, 12 and 24 weeks

Title

Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks

Description

Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage

Time Frame

Baseline, 12 and 24 weeks

Title

Change in plasma insulin from baseline to 12 and 24 weeks

Description

Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL

Time Frame

Baseline, 12 and 24 weeks

Title

Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks

Description

Calculated from: HOMA-IR = (insulin x glucose)/405

Time Frame

Baseline, 12 and 24 weeks

Secondary Outcome Measure Information:

Title

Change in plasma cytokines from baseline to 12 and 24 weeks

Description

Time Frame

Baseline, 12 and 24 weeks

Title

Change in plasma adipokines from baseline to 12 and 24 weeks

Description

Adiponectin, resistin and leptin, measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL

Time Frame

Baseline, 12 and 24 weeks

Title

Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks

Description

Time Frame

Baseline, 12 and 24 weeks

Title

Change in lipid profile from baseline to 12 and 24 weeks

Description

Total cholesterol, HDL-, LDL-, Very Low Density Lipoprotein (VLDL)-cholesterol and triacylglycerides, measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL

Time Frame

Baseline, 12 and 24 weeks

Title

Changes in markers of oxidative stress from baseline to 12 and 24 weeks

Description

Time Frame

Baseline, 12 and 24 weeks

Title

Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks

Description

Cluster of desgination 4, 8, 17 and 19 (CD4+, CD8+, CD17+ and CD19+), measured by flow cytometry (Becton Dickinson Facs AriaMR de 6 canales), in percentage

Time Frame

Baseline, 12 and 24 weeks

Title

Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks

Description

Analyzed with a Illumina sequencing equipment and Mothur y Stamp softwares, in percentage

Time Frame

Baseline, 12 and 24 weeks

Other Pre-specified Outcome Measures:

Title

Change in plasma vitamin C from baseline to 12 and 24 weeks

Description

Measured with a Colorimetric assay, in mg/dL

Time Frame

Baseline, 12 and 24 weeks

Title

Changes in plasma vitamin D from baseline to 12 and 24 weeks

Description

Measured with a commercial ELISA kit, ng/mL

Time Frame

Baseline, 12 and 24 weeks

Title

Changes in plasma zinc from baseline to 12 and 24 weeks

Description

Measured with a Colorimetric assay, in mg/dL

Time Frame

Baseline, 12 and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's). Severe renal insufficiency. Nephrolithiasis or history of nephrolithiasis. Hyperoxaluria. Hemochromatosis. Hypercalcaemia. Hypervitaminosis D. Using insulin. Be taking drugs such as desferrioxamine, iron, cyclosporine, indinavir (protease inhibitors), warfarin, thiazide diuretic, orlistat, ion exchange resins (e.g cholestyramine, laxatives (e.g. mineral oil, senna), vitamin d analogues (e.g. ergocalciferol, calcitriol, and topical calcipotriene), tetracycline antibiotics, quinolone antibiotics, penicillamine, biphosphonates, levothyroxine, eltrombopag. Patients with hypersensitivity to any of the active substance(s) or to any of the excipients. Hypersensitivity to the by-products including honey, conifers, poplars, Peru balsam, and salicylate. Intake of probiotics or supplemental vitamin or mineral (vitamin D, C, zinc or calcium) for 4 weeks before the beginning of the study. Smoking and alcohol consumption (> 40 gr/ day for men and 25 gr/ day for women. Pregnant or lactating. Whose parents or grandparents are/were immigrant or of native origin.