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

NCT03734445 | Unknown DMC

• 1 other identifier: 2018/11
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Change in plasma cytokines from baseline to 12 and 24 weeks

  Baseline, 12 and 24 weeks

• Change in plasma adipokines from baseline to 12 and 24 weeks

  Baseline, 12 and 24 weeks

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

  Baseline, 12 and 24 weeks

• Change in lipid profile from baseline to 12 and 24 weeks

  Baseline, 12 and 24 weeks

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

  Baseline, 12 and 24 weeks

Other Outcomes (3)

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

  Baseline, 12 and 24 weeks

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

  Baseline, 12 and 24 weeks

• Changes in plasma zinc from baseline to 12 and 24 weeks

  Baseline, 12 and 24 weeks

Study Arms (2)

Vitamin supplement

EXPERIMENTAL

Effervescent tablets containing Vitamin C, Vitamin D and zinc

Dietary Supplement: Vitamin Supplement

Placebo

PLACEBO COMPARATOR

Effervescent tablets not containing Vitamin C, Vitamin D and zinc

Other: Placebo

Interventions

Vitamin Supplement DIETARY_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

Vitamin supplement

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma del Estado de Mexico: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DSc, Head of Nutrition and Health Group, Full-time professor

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: November 8, 2018
• Study Start: January 9, 2020
• Primary Completion: January 9, 2020
• Study Completion: March 26, 2020
• Last Updated: October 1, 2019

Record last verified: 2018-11