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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03734445
• Other study ID #: 2018/11
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: March 26, 2020

Study information

• Verified date: November 2018
• Source: Universidad Autonoma del Estado de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 26, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Vitamin Supplement
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

Other:
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma del Estado de Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma vitamin C from baseline to 12 and 24 weeks	Measured with a Colorimetric assay, in mg/dL	Baseline, 12 and 24 weeks
Other	Changes in plasma vitamin D from baseline to 12 and 24 weeks	Measured with a commercial ELISA kit, ng/mL	Baseline, 12 and 24 weeks
Other	Changes in plasma zinc from baseline to 12 and 24 weeks	Measured with a Colorimetric assay, in mg/dL	Baseline, 12 and 24 weeks
Primary	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	Baseline, 12 and 24 weeks
Primary	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	Baseline, 12 and 24 weeks
Primary	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	Baseline, 12 and 24 weeks
Primary	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	Baseline, 12 and 24 weeks
Secondary	Change in plasma cytokines from baseline to 12 and 24 weeks	Tumor Necrosis Factor alfa (TNFa), Interferon gamma (IFN-?), Interleukins 1 beta, 4, 6 and 10 (IL-1ß, IL4, IL-6, IL10) & transforming growth factor beta (TGF-ß), measured with Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in pg/mL	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks
Secondary	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	Baseline, 12 and 24 weeks